BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1144208 · Received August 29, 2008

    Report

    Report Number
    2182207-2008-05360
    Event Type
    Injury
    Date Received
    August 29, 2008
    Report Date
    August 1, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: CHAN MKY, TJANDRA JJ. SACRAL NERVE STIMULATION FOR FECAL INCONTINENCE: EXTERNAL ANAL SPHINCTER DEFECT VS. INTACT ANAL SPHINCTER. DIS COLON RECTUM. 2008;51(7):1015-1025. THIS PROSPECTIVE STUDY WAS DESIGNED TO ASSESS THE EFFECTIVENESS OF SACRAL NERVE STIMULATION FOR FECAL INCONTINENCE IN PATIENTS WITH EXTERNAL ANAL SPHINCTER DEFECT AND TO EVALUATE ITS EFFICACY REGARDING PRESENCE AND SIZE OF SPHINCTER DEFECT. FIFTY-THREE CONSECUTIVE PATIENTS WHO UNDERWENT SACRAL NERVE STIMULATION FOR FECAL INCONTINENCE WERE DIVIDED INTO TWO GROUPS: EXTERNAL ANAL SPHINCTER DEFECT GROUP (N=21) VS. INTACT SPHINCTER GROUP (N=32). FOLLOWUP WAS PERFORMED AT 3, 6, AND 12 MONTHS WITH ANORECTAL PHYSIOLOGY. WEXNER'S SCORE, BOWEL DIARY, AND QUALITY OF LIFE QUESTIONNAIRES. REPORTABLE EVENT: ONE PATIENT HAD SEROMA, WHICH RESOLVED AFTER PERCUTANEOUS ASPIRATION.

    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 Other LEAD MODEL 3080 N=1| PROGRAMMER MODEL 7432 N=1