BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2100649 · Received May 17, 2011

    Report

    Report Number
    3007566237-2011-03597
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    March 1, 2010
    Report Date
    May 31, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): (CONSTIPATION). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PT. THE PT INFO PROVIDED IS THE AVERAGE FOR ALL THE PTS. AT THIS TIME, NO ADDITIONAL INFO WAS AVAILABLE, ADDITIONAL INFO REGARDING THE PT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: SHARPE A, READ A. "SACRAL NERVE STIMULATION FOR THE MGMT OF FAECAL INCONTINENCE." BRITISH JOURNAL OF NURSING (MARK ALLEN PUBLISHING). APR 8-21 2010;19(7):415-419. SUMMARY: THIS ARTICLE LOOKED AT THE RESULTS OF PTS WHO HAD SACRAL NERVE STIMULATION PERFORMED FOR FECAL INCONTINENCE BETWEEN 2001 AND 2008 AT THE COLORECTAL UNIT AT THE (B)(6). AT THE TIME OF PUBLICATION, 44 PTS HAD UNDERGONE PERMANENT IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG). REPORTABLE EVENT: ONE PT DEVELOPED INFECTION AROUND THE STIMULATOR THAT REQUIRED REMOVAL OF THE DEVICE. THREE PTS DEVELOPED INFECTION AROUND THE IPG THAT DID NOT REQUIRE REMOVAL OF THE DEVICE. FOUR PTS HAD EITHER THE IPG OR THE LEAD REPOSITIONED DUE TO PAIN OR MIGRATION. ONE PT HAD THE IPG EXPLANTED DUE TO BREAKDOWN OF THE WOUND AND EROSION OF THE LEAD THROUGH THE SKIN. ONE PT HAD DAMAGE TO THE LEAD FROM UNIPOLAR DIATHERMY DURING AN UNRELATED EMERGENCY SURGICAL PROCEDURE. THE PT SUBSEQUENTLY HAD A NEW STIMULATOR IMPLANTED WITH GOOD OUTCOME. ONE PT DEVELOPED CONSTIPATION WITH THE STIMULATION AND WAS USING RECTAL IRRIGATION. ONE PT REQUIRED IMMEDIATE REPOSITIONING OF THE IPG DUE TO PAIN AND SUBSEQUENTLY HAD A SUCCESSFUL OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R IPG: MODELS UNK| LEAD: MODELS UNK