BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 1936173 · Received December 14, 2010

    Report

    Report Number
    3007566237-2010-10440
    Event Type
    Injury
    Date Received
    December 14, 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 ADDITIONAL INFO WAS AVAILABLE, ADDITIONAL 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 RECEIVED IMPLANTS. FROM (B)(6) 2001 TO AUGUST 2009, (B)(6) PTS ((B)(6) WOMEN) OF MEAN AGE 56 YEARS WERE OPERATED ON FOR NEUROLOGICAL (N=104) OR IDIOPATHIC (N=19) FECAL INCONTINENCE. EIGHTY-SEVEN PTS (B)(6) HAD A POSITIVE TEST AND UNDERWENT STIMULATOR IMPLANTATION. ANY STIMULATOR DYSFUNCTION WAS PROSPECTIVELY STUDIED. AMONG THE (B)(6) PTS, (B)(6) 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 (B)(6) PTS, (B)(6) HAD REMOVAL OF THE STIMULATOR DURING FOLLOW-UP. REPORTABLE EVENT: IT WAS REPORTED THAT ONE PT (A (B)(6) FEMALE) EXPERIENCED IMPLANT-RELATED PAIN THAT LED TO THE RE-INTERVENTION AND REPOSITIONING AT 24 MONTHS WITH AN UNEVENTFUL OUTCOME. THE SOURCE LITERATURE DID NOT SPECIFY WHICH DEVICE MODELS WERE USED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention IMPLANTED:| EXPLANTED:| LEAD: MODEL LEAD URO, LOT# UNK