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Fda Release 2/28/2007

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  • tigger_gal
    diffently.. I just wanted everyone to see this, so if they are considering getting the stim they need to tell their doctor about it.

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  • DebbieB
    Very Interesting Cindy !!!

    In this person case any kind of surgery , having cardiomegaly would have been the same out come , it is to bad that the doctor that was doing this or anesthesiologist have known this and it could of been avoided !!


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  • Sarojini
    That's correct

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  • tigger_gal
    Yes, I understood it as you did, but it is saying if you have this condition you are not a candidate for the stim surgery, or any surgery.

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  • Sarojini
    Interesting. However, it sounds like the manner of death really had nothing to do with the Stim and is reported as due to natural causes -- the woman had cardiomegaly, which is an enlargement of the heart which often goes undiagnosed until autopsy.

    However, because she had the Interstim, it had to be reported to the company and to the FDA. This goes back to what I was saying once before -- with all medical studies, and with all medical devices, ANY deaths of patients in the study or with the device must be reported to the FDA and the device manufacturer.

    However, it sounds like the family of the woman is suing... I wish them luck, but cardiomegaly is usually genetic and doesn't have anything to do with an InterStim. The only thing I can think of is that since the anesthesiologist did not know about the cardiomegaly, the doses of anesthesia caused the death.

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  • tigger_gal
    started a topic Fda Release 2/28/2007

    Fda Release 2/28/2007

    Adverse Event Report
    MED REL, JUNCOS INTERSTIM IPG back to search results

    Model Number 3023
    Event Date 06/22/2005
    Event Type Other Patient Outcome Death; Other
    Event Description
    The manufacturer was notified on june 29, 2006, that the following event is now a legal file. The patient underwent placement of a stage i interstim system as an outpatient on june 22, 2005. Shortly thereafter, she was found to be unresponsive. Autopsy report indicated the cause of death to be cardiomegaly and the manner of death to be natural.

    Search Alerts/Recalls (Contained in Enforcement Reports)
    (After selecting, enter device information to search Alerts/Recalls)

    new search | submit an adverse event report

    Brand Name INTERSTIM
    Type of Device IPG
    Manufacturer (Section F) MED REL, JUNCOS
    road 31, km. 24, hm 4
    ceiba norte industrial park
    juncos PR 00777

    Manufacturer (Section D) MED REL, JUNCOS
    road 31, km. 24, hm 4
    ceiba norte industrial park
    juncos PR 00777

    Manufacturer (Section G) MED REL, JUNCOS
    road #31 km 24 hm 4,
    ceiba norte industrial park
    juncos PR 00777

    Manufacturer Contact marie holm
    4000 lexington avenue north
    shoreview , MN 55126
    (800) 328 -0810

    Device Event Key 729640
    MDR Report Key 741793
    Event Key 706887
    Report Number 3004209178-2006-1224
    Device Sequence Number 1
    Product Code GZB
    Report Source Manufacturer
    Source Type Other
    Reporter Occupation Physician
    Remedial Action Other
    Type of Report Initial
    Report Date 06/29/2006
    1 Device Was Involved in the Event
    1 Patient Was Involved in the Event
    Date FDA Received 07/27/2006
    Is This An Adverse Event Report? Yes
    Is This A Product Problem Report? No
    Device Operator Health Professional
    Device MODEL Number 3023
    Device Catalogue Number 3023
    Was Device Available For Evaluation? No
    Is The Reporter A Health Professional? Yes
    Was the Report Sent to FDA? No
    Date Manufacturer Received 06/29/2006
    Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
    Is The Device Single Use? Yes
    Is this a Reprocessed and Reused Single-Use Device? No
    Is the Device an Implant? Yes
    Is this an Explanted Device? No Answer Provided
    Type of Device Usage Initial

    Database last updated on February 28, 2007

    Product Classification Database
    Device stimulator, spinal-cord, implanted (pain relief)
    Regulation Description Implanted spinal cord stimulator for pain relief.
    Regulation Medical Specialty Neurology
    Review Panel Neurology
    Product Code GZB
    Submission Type 510(k)
    Regulation Number 882.5880
    Device Class 2
    GMP Exempt? No
    Third Party Review Not Third Party Eligible
    Database Updated 3/07/2007
    Last edited by tigger_gal; 03-27-2007, 02:57 AM.