BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 1936120 · Received December 13, 2010

    Report

    Report Number
    3007566237-2010-10395
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    May 15, 2010
    Report Date
    December 2, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. AT THIS TIME NO ADD'L INFO WAS AVAILABLE, ADD'L INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: FAUCHERON JL, VOIRIN D, BADIC B. SACRAL NERVE STIMULATION FOR FECAL INCONTINENCE: CAUSES OF SURGICAL REVISION FROM A SERIES OF 87 CONSECUTIVE PTS OPERATED ON IN A SINGLE INSTITUTION. DIS COLON RECTUM. NOV 2010;53(11):1501-1507. SUMMARY: THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE CAUSES OF SURGICAL REVISION FOLLOWING SACRAL NERVE STIMULATION IN CONSECUTIVE PTS WHO HAD REC'D IMPLANTS. FROM (B)(6) 2001 TO (B)(6) 2009, 123 PTS (105 WOMEN) OF MEAN AGE 56 YRS WERE OPERATED ON FOR NEUROLOGICAL (N=104) OR IDIOPATHIC (N=19) FECAL INCONTINENCE. EIGHTY-SEVEN PTS OF 123 HAD A POSITIVE TEST AND UNDERWENT STIMULATOR IMPLANTATION. ANY STIMULATOR DYSFUNCTION WAS PROSPECTIVELY STUDIED. AMONG THE 87 PTS, 36 HAD SURGICAL REVISION OF THE DEVICE FOR THE FOLLOWING REASONS: DEVICE-RELATED FAILURE DUE TO INFECTION, ELECTRODE DISPLACEMENT OR BREAKAGE, AND DYSFUNCTION OWING TO IMPEDANCE INCREASE OF THE SYSTEM; ADVERSE STIMULATION WITH PAIN; BATTERY DEPLETION EITHER OF GENERATOR END OF LIFE OR MRI; AND LOSS OF CLINICAL EFFICACY. AMONG THE 87 PTS, 21 HAD REMOVAL OF THE STIMULATOR DURING F/U. REPORTABLE EVENT: ONE PT (A (B)(6)FEMALE), IN WHOM THE SURGEON NOTICED A SIMPLE ERYTHEMA AT THE EXIT SPOT OF THE EXTENSION AFTER THE 3-WEEK TEST PERIOD, HAD A BACTERIOLOGICAL SKIN SAMPLE WHICH WAS NEGATIVE FOR ANY AGGRESSIVE ORGANISM. THE DERMATOLOGIST CONCLUDED THAT THERE WAS NO INFECTION. THE STIMULATOR WAS THEN IMPLANTED BUT THE SITE OF THE IMPLANT BECAME INFECTED 45 DAYS LATER; THE STIMULATOR AND THE LEAD WERE REMOVED THE FOLLOWING WEEK; THE INFECTION SETTLED RAPIDLY, SO THAT A NEW IMPLANT WAS OFFERED TO THE PT 9 MONTHS LATER, WITH SUCCESS. THE SOURCE LITERATURE DID NOT SPECIFY WHICH DEVICE MODELS WERE USED. SEE LITERATURE ARTICLE WITH MFR REPORT# 3007566237201010392.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN EZW MEDTRONIC NEUROMODULATION IPG URO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention LEAD: MODEL LEAD URO, LOT# UNKNOWN| EXPLANTED:| IMPLANTED: