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Statement on back cover of Interstim Booklet from Medtronics
On the back cover of the information booklet that you are suppose to be provided with before having this surgery states:
"Precautions/Adverse Events:
Saftey and effectiveness have not been established for: bilateral stimulation, patients with neurological disease origins such as multiple sclerosis, pregnancy and delivery, or for pediatric use under the age of 16. System may be affected by or adversely affect cardiac pacemaker or therapies, cardioverter defibillators, diathermy, elcetrocautery, external defibrillatios, ultrasonic equipment, rediation therapy, magnetic resonance imaging (MRI), theft detectors and screening devices. Adverse events related to the therapy, device or procedure can include: pain at the implant sites, lead migration or skin irritation, technical or device problems, transient electric shock, adverse change in bowel or voiding function, numbness, nerve injury, seroma at the neurostimulator site, change in menstrual cycle, and undesirable stimulation or sensations."
I had my first surgery in Oct 1999 and even tho I did read the booklet, I did NOT read the back cover. Even if I would have, it probably wouldn't have mattered but now that it DOES matter, it sure makes me wish that I had learned a little more before I had this implant done.....
The date on the back of this booklet is 1999, I have no idea if there is a recent one.......
"Precautions/Adverse Events:
Saftey and effectiveness have not been established for: bilateral stimulation, patients with neurological disease origins such as multiple sclerosis, pregnancy and delivery, or for pediatric use under the age of 16. System may be affected by or adversely affect cardiac pacemaker or therapies, cardioverter defibillators, diathermy, elcetrocautery, external defibrillatios, ultrasonic equipment, rediation therapy, magnetic resonance imaging (MRI), theft detectors and screening devices. Adverse events related to the therapy, device or procedure can include: pain at the implant sites, lead migration or skin irritation, technical or device problems, transient electric shock, adverse change in bowel or voiding function, numbness, nerve injury, seroma at the neurostimulator site, change in menstrual cycle, and undesirable stimulation or sensations."
I had my first surgery in Oct 1999 and even tho I did read the booklet, I did NOT read the back cover. Even if I would have, it probably wouldn't have mattered but now that it DOES matter, it sure makes me wish that I had learned a little more before I had this implant done.....
The date on the back of this booklet is 1999, I have no idea if there is a recent one.......