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INTERSTIM BLADDER STIMULATOR MEDTRONIC Reports 1998-2010
Medical Device Brand Name: MEDTRONIC
Medical Device Generic Name: INTERSTIM BLADDER STIMULATOR
Medical Device Manufacturer Name:MEDTRONIC


INTERSTIM BLADDER STIMULATOR MEDTRONIC Report # 571829
MEDTRONIC INTERSTIM PULSE GENERATOR AND LEAD THAT WAS PUT IN BY ANOTHER UROLOGIST 2 MONTHS AGO FORMED ABSCESS AND RPTR HAD TO DO EMERGENCY SURGERY TO REMOVE ALL THE COMPONENTS. THE REASON RPTR IS REPORTING IS THAT THIS IS THE SECOND CASE IN JAN. 2005 OF INTERSTIM ABSCESS AND RPTR HAD TO DO EMERGENCY SURGERY ON. RPTR IS WORRIED THAT THERE IS A SYSTEMATIC AND REGULATORY PROBLEM IN THE NEW AND MODIFIED TECHNIQUE THAT MEDTRONIC IS RECOMMENDING TO THE DOCTORS: A 2 STAGE SURGERY WHEREBY THE LEAD THAT EXITS THE SKIN NEAR THE BUTTOCK IS INTERNALIZED TO A PULSE GENERATOR. MAYBE A 2 STAGE PROCEDURE IS FINE FOR A HEART PACEMAKER BUT RPTR IS CONCERNED THAT THE BUTTOCK AREA IS NOT CLEAN ENOUGH FOR THIS METHOD. RPTR WONDERS IF THERE IS SUFFICIENT DATA TO WARRANT THIS RECOMMENDATION AND APPROVAL. RPTR CANNOT BELIEVE THAT THE SAFETY DATA FOR A HEART PACEMAKER CAN BE APPLIED FOR BELOW THE WAIST. CONCERNED THAT MORE OF THESE STIMULATORS ARE BEING REMOVED FOR INFECTION BECAUSE OF THIS POTENTIAL ERROR IN TECHNIQUE. BOTH PTS HAD POSITIVE CULTURE AT THE LEAD SITE. RPTR WANTS TO KNOW IF THERE IS ANYTHING THEY SHOULD DO.

INTERSTIM BLADDER STIMULATOR MEDTRONIC Report # 571829
MEDTRONIC INTERSTIM PULSE GENERATOR AND LEAD THAT WAS PUT IN BY ANOTHER UROLOGIST 2 MONTHS AGO FORMED ABSCESS AND RPTR HAD TO DO EMERGENCY SURGERY TO REMOVE ALL THE COMPONENTS. THE REASON RPTR IS REPORTING IS THAT THIS IS THE SECOND CASE IN JAN. 2005 OF INTERSTIM ABSCESS AND RPTR HAD TO DO EMERGENCY SURGERY ON. RPTR IS WORRIED THAT THERE IS A SYSTEMATIC AND REGULATORY PROBLEM IN THE NEW AND MODIFIED TECHNIQUE THAT MEDTRONIC IS RECOMMENDING TO THE DOCTORS: A 2 STAGE SURGERY WHEREBY THE LEAD THAT EXITS THE SKIN NEAR THE BUTTOCK IS INTERNALIZED TO A PULSE GENERATOR. MAYBE A 2 STAGE PROCEDURE IS FINE FOR A HEART PACEMAKER BUT RPTR IS CONCERNED THAT THE BUTTOCK AREA IS NOT CLEAN ENOUGH FOR THIS METHOD. RPTR WONDERS IF THERE IS SUFFICIENT DATA TO WARRANT THIS RECOMMENDATION AND APPROVAL. RPTR CANNOT BELIEVE THAT THE SAFETY DATA FOR A HEART PACEMAKER CAN BE APPLIED FOR BELOW THE WAIST. CONCERNED THAT MORE OF THESE STIMULATORS ARE BEING REMOVED FOR INFECTION BECAUSE OF THIS POTENTIAL ERROR IN TECHNIQUE. BOTH PTS HAD POSITIVE CULTURE AT THE LEAD SITE. RPTR WANTS TO KNOW IF THERE IS ANYTHING THEY SHOULD DO.


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Source: Manufacturer and User Facility Device Experience Database - (MAUDE). MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19. MAUDE is scheduled to be updated quarterly and the search page reflects the date of the most recent update. MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices. Please be aware that reports regarding device trade names may have been submitted under different manufacturer names. Searches only retrieve records that contain the search term(s) provided by the requester. The data is updated on a quarterly basis. DISCLAIMER: Section 21 CFR 803.16 states that "A report or other information submitted by a reporting entity under this part, and any release by FDA of that report or information, does not necessarily reflect a conclusion by the party submitting the report or by FDA that the report or information constitutes an admission that the device, or the reporting entity or its employees, caused or contributed to the reportable event. The reporting entity need not admit and may deny that the report or information submitted under this part constitutes an admission that the device, the party submitting the report, or employees thereof, caused or contributed to a reportable event." In addition, some firms have submitted their own additional disclaimer statements. A file of those disclaimers will be placed on the web shortly.
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