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  • Safety alert from 2001 from medtronics

    Safety Alert

    For more information

    For Physicians

    CONTRAINDICATION: Do not use shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and can cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death.

    Diathermy is further prohibited because it can also damage the neurostimulation system components resulting in loss of therapy, requiring additional surgery for system explantation and replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned “on” or “off.” Advise your patients to inform all their health care professionals that they should not be exposed to diathermy treatment.




    May 16, 2001

    ':

    Medtronic Neurological is issuing this Safety Alert to all physicians, patients and facilities involved with its implanted neurostimulation systems, which include:

    Activa® Systems for deep brain stimulation (DBS)
    Spinal Cord and Peripheral Nerve Stimulation Systems
    InterStim® Therapy (Sacral Nerve Stimulation)
    Enterra® Therapy
    Dynamic Graciloplasty
    DO NOT use or prescribe shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy (all now referred to as diathermy) for patients implanted with any type of Medtronic neurostimulation system. Use of diathermy on patients with any implanted neurostimulation device can cause heating at the tissue/stimulation electrode interface, which under certain circumstances can result in permanent tissue or nerve damage. Such tissue damage could lead to permanent injury or even death. The exact nature of the tissue or nerve damage depends on the location of the stimulation electrodes implanted in the patient (e.g. brain, spinal cord, sacral nerve, stomach), and the extent of the exposure to diathermy treatment.

    This contraindication applies regardless of where the diathermy treatment is targeted on the patient’s body in relation to the implanted stimulation system.
    This contraindication applies regardless of whether it is used to deliver heat or no heat.
    This contraindication applies regardless of whether the Medtronic neurostimulation system is turned “on” or “off”.
    This contraindication applies if any individual components of the neurostimulation system remain implanted in the body.
    Medtronic is issuing new labeling for its neurostimulation systems using the contraindication language printed above. A patient-friendly version of the above contraindication language will appear in patient manuals and materials. The FDA has been notified of this issue and of Medtronic’s notification plans.

    What are shortwave diathermy, microwave diathermy and therapeutic ultrasound diathermy treatments?
    Diathermy treatments are used by a variety of health care professionals, including physical therapists, nurses, chiropractors, dentists, sports therapists, and others. Health care professionals may refer to diathermy using the term “deep heat” or similar terms. Diathermy means deep heat, but these devices may also be used in a way that causes little or no heating. Diathermy does not include ultrasonic imaging or electrocautery devices. Diathermy that uses these forms of energy (shortwave, microwave or ultrasound) can cause permanent nerve or tissue damage in patients with a neurostimulation system even if the diathermy is set at power levels that do not cause deep heating.
    Diathermy (d_´-a-thur-m_) are treatments that deliver energy to treat specific areas of the body. These treatments are typically used for the following purposes:

    relieve pain, stiffness and muscle spasms
    reduce joint contractures
    reduce swelling and pain after surgery
    promote wound healing
    The contraindication with implantable neurostimulation devices applies to all forms of diathermy.

    Risk to Patients:
    Medtronic has received two case reports of patients implanted with deep brain stimulation systems who received shortwave therapy (diathermy), one following oral surgery, the other for treatment of chronic scoliosis. In both cases, the shortwave energy caused severe and permanent brain damage in the area of the lead electrodes implanted in the brain. Both patients remain in a comatose condition since receiving shortwave diathermy.

    As a result of the above case reports, Medtronic conducted tests on a neurostimulation system with one type of shortwave diathermy device. The tests found that the energy generated by the shortwave type of diathermy will cause heating well above the temperatures required for tissue destruction.

    Due to the widespread use of diathermy for a variety of therapeutic treatments in the health care community, it is reasonable to assume that all patients with implanted neurostimulation systems can be at risk of exposure to diathermy therapy.

    Impact on Neurostimulation Systems:
    Please note that the permanent nerve or tissue injury is not caused by a device malfunction. Rather, it is caused by the interaction of two devices (neurostimulation system and diathermy machine) when they are working properly. Medtronic has previously cautioned against diathermy, as it poses a risk of damage to the implanted device. Although the testing subsequent to the reported events did not show damage to the Medtronic device, Medtronic continues to believe that diathermy of any type poses a real risk of damage to implanted neurostimulation devices and should be avoided. Other types of diathermy equipment have not been tested, and the specific effects of any individual diathermy system on the neurostimulation systems are unknown. Routine interrogation of the implanted neurostimulation device can ascertain its functional integrity.

    If you have any questions related to this Safety Alert or any other safety issues regarding Medtronic’s implantable neurostimulation devices, please contact Medtronic’s Technical Service line at 1-800-328-0810. Please refer to the technical manuals provided with your Medtronic products to review the entire list of other contraindications, precautions, and warnings regarding the safe use of these devices.

  • #2
    Yet another one from 2001

    For Physicians


    CONTRAINDICATION: Do not use shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and can cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death.

    Diathermy is further prohibited because it can also damage the neurostimulation system components resulting in loss of therapy, requiring additional surgery for system explantation and replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned “on” or “off.” Advise your patients to inform all their health care professionals that they should not be exposed to diathermy treatment.


    May 16, 2001

    Dear Doctor and Medical Staff:

    Medtronic Neurological is issuing this Safety Alert to all physicians, patients and facilities involved with its implanted neurostimulation systems, which include:

    Activa® Systems for deep brain stimulation (DBS)
    Spinal Cord and Peripheral Nerve Stimulation Systems
    InterStim® Therapy (Sacral Nerve Stimulation)
    Enterra® Therapy
    Dynamic Graciloplasty
    DO NOT use or prescribe shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy (all now referred to as diathermy) for patients implanted with any type of Medtronic neurostimulation system. Use of diathermy on patients with any implanted neurostimulation device can cause heating at the tissue/stimulation electrode interface, which under certain circumstances can result in permanent tissue or nerve damage. Such tissue damage could lead to permanent injury or even death. The exact nature of the tissue or nerve damage depends on the location of the stimulation electrodes implanted in the patient (e.g. brain, spinal cord, sacral nerve, stomach), and the extent of the exposure to diathermy treatment.

    This contraindication applies regardless of where the diathermy treatment is targeted on the patient’s body in relation to the implanted stimulation system.
    This contraindication applies regardless of whether it is used to deliver heat or no heat.
    This contraindication applies regardless of whether the Medtronic neurostimulation system is turned “on” or “off”.
    This contraindication applies if any individual components of the neurostimulation system remain implanted in the body.
    Medtronic is issuing new labeling for its neurostimulation systems using the contraindication language printed above. A patient-friendly version of the above contraindication language will appear in patient manuals and materials. The FDA has been notified of this issue and of Medtronic’s notification plans.

    What are shortwave diathermy, microwave diathermy and therapeutic ultrasound diathermy treatments?
    Diathermy treatments are used by a variety of health care professionals, including physical therapists, nurses, chiropractors, dentists, sports therapists, and others. Health care professionals may refer to diathermy using the term “deep heat” or similar terms. Diathermy means deep heat, but these devices may also be used in a way that causes little or no heating. Diathermy does not include ultrasonic imaging or electrocautery devices. Diathermy that uses these forms of energy (shortwave, microwave or ultrasound) can cause permanent nerve or tissue damage in patients with a neurostimulation system even if the diathermy is set at power levels that do not cause deep heating.
    Diathermy (dî´-a-thur-mê) are treatments that deliver energy to treat specific areas of the body. These treatments are typically used for the following purposes:

    relieve pain, stiffness and muscle spasms
    reduce joint contractures
    reduce swelling and pain after surgery
    promote wound healing
    The contraindication with implantable neurostimulation devices applies to all forms of diathermy.

    Risk to Patients:
    Medtronic has received two case reports of patients implanted with deep brain stimulation systems who received shortwave therapy (diathermy), one following oral surgery, the other for treatment of chronic scoliosis. In both cases, the shortwave energy caused severe and permanent brain damage in the area of the lead electrodes implanted in the brain. Both patients remain in a comatose condition since receiving shortwave diathermy.

    As a result of the above case reports, Medtronic conducted tests on a neurostimulation system with one type of shortwave diathermy device. The tests found that the energy generated by the shortwave type of diathermy will cause heating well above the temperatures required for tissue destruction.

    Due to the widespread use of diathermy for a variety of therapeutic treatments in the health care community, it is reasonable to assume that all patients with implanted neurostimulation systems can be at risk of exposure to diathermy therapy.

    Impact on Neurostimulation Systems:
    Please note that the permanent nerve or tissue injury is not caused by a device malfunction. Rather, it is caused by the interaction of two devices (neurostimulation system and diathermy machine) when they are working properly. Medtronic has previously cautioned against diathermy, as it poses a risk of damage to the implanted device. Although the testing subsequent to the reported events did not show damage to the Medtronic device, Medtronic continues to believe that diathermy of any type poses a real risk of damage to implanted neurostimulation devices and should be avoided. Other types of diathermy equipment have not been tested, and the specific effects of any individual diathermy system on the neurostimulation systems are unknown. Routine interrogation of the implanted neurostimulation device can ascertain its functional integrity.

    If you have any questions related to this Safety Alert or any other safety issues regarding Medtronic’s implantable neurostimulation devices, please contact Medtronic’s Technical Service line at 1-800-328-0810. Please refer to the technical manuals provided with your Medtronic products to review the entire list of other contraindications, precautions, and warnings regarding the safe use of these devices.



    Sincerely,



    Cliff Owens
    Vice President and General Manager
    Medtronic Neurostimulation Martha Goldberg Aronson
    Vice President and General Manager
    Medtronic Functional Stimulation

    Comment


    • #3
      Thanks!!!! I also thought if you had the Interstim you should avoid MRI's. Dont they use magnets when doing this procedure??? Just another thought.
      God grant me the serinity to withstand the days ahead!!!

      My myspace link...
      www.myspace.com/patricia_luvs_matt


      Patricia

      In Memory of My Father (Lawerence) 1/25/2007

      Procedures:
      Interstim Sept 2001
      1st InterStim Removal May 2005
      2nd Interstim Implanted May 2005
      2nd InterStim Removed March 2007
      Hysterectomy 1999
      Tubes Tied 1997
      C-Section 1996


      Me and my kids


      Taylor (my daughter) Me and my daughter My son Cody and Taylor

      Comment


      • #4
        That is true

        That is all true and I knew about those patients in comas.
        You cannot have any of those procedures. I found out after implant, but
        fortunately I found out right away and therefore I never had anything like that done ever. I was also told after that you cannot have MRI's and thus I never had any while my implant was in. I have just had them since it was taken out to confirm and look for damage. My regular uro had told me with it in to stay away from MRI's and the above information I found soon after mine was implanted. It is correct those treatments effect the functioning and so on of the device and cause damage to it or you, or both.
        Patricia my friend in LA..cannot remember this new doctor's name. She said he practices there in Shreveport and also does a clinic in Bossier ..so I am assuming she saw him in Bossier. When is your surgery so I can keep you in my prayers. Have someone contact me or here on the boards and let us know how you are doing.
        Everyone I wish you the best day absolutely possible for you no matter what your facing today. There is always tomorrow and it may be even better.
        I am waiting on the surgeon to decide if he is going to operate on my good leg's knee as the knee isn't doing well and a decision needs to be made. If I hurt where my damage is and all in the spine for time more than normal then it is worth it to me to get the knee fixed as it is causing trouble anyway on the left side. The sun is finally out here however and I hope to spend some time today on my butt doing flower beds..as they so help me and I so enjoy them.
        Have a wonderful day today
        Dusty

        Comment

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