BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1250370 · Received December 3, 2008

    Report

    Report Number
    2182207-2008-07966
    Event Type
    Injury
    Date Received
    December 3, 2008
    Report Date
    November 6, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: FAUCHERON JL, BOST R, DUFFOURNET V, DUPUY S, CARDIN N, BONAZ B. SACRAL NEUROMODULATION IN THE TREATMENT OF SEVERE ANAL INCONTINENCE. FORTY CONSECUTIVE CASES TREATED IN ONE INSTITUTION. GASTROENTEROL CLIN BIOL. MAY 2006;30(5):669-672. SACRAL NEUROMODULATION IS A RECOGNIZED THERAPEUTIC OPTION IN SEVERE ANAL INCONTINENCE FROM NEUROGENIC ORIGINS, WHEN MEDICAL TREATMENT HAS FAILED. TWENTY NINE PATIENTS HAD A POSITIVE TEST AND WERE IMPLANTED. REPORTABLE EVENT: ONE PATIENT HAD SUDDEN WORSENING OF THE FUNCTIONAL RESULTS ASSOCIATED WITH A SENSATION OF ELECTRICAL DISCHARGE AND BURNING IN THE BUTTOCKS WHEN THE AMPLITUDE WAS INCREASED, CONFIRMED DIAGNOSIS OF A DISPLACED ELECTRODE. THIS COMPLICATION WAS CONFIRMED BY TDM AND A ANEW ELECTRODE WAS SUCCESSFULLY IMPLANTED UNDER GENERAL ANESTHESIA. THE CAUSE OF DISPLACEMENT WAS NOT IDENTIFIED. SEE MFG REPORT # 2182207-2008-07948.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC NEUROMODULATION 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization LEAD: MODEL UNK N=1| PROGRAMMER: MODEL UNK N=1| EXTENSION: MODEL UNK N=1