BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2191774 · Received July 22, 2011

    Report

    Report Number
    3007566237-2011-05714
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    March 1, 2011
    Report Date
    July 18, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AF
    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 REGARDING THE PTS AND EVENT HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: MARCELISSEN TA, LEONG RK, SERROYEN J, VAN KERREBROECK PE, DE WACHTER SG. THE USE OF BILATERAL SACRAL NERVE STIMULATION IN PTS WITH LOSS OF UNILATERAL TREATMENT EFFICACY. THE JOURNAL OF UROLOGY. MAR 2011; 185(3): 976-980. SUMMARY: THE AUTHORS EVALUATED BILATERAL SACRAL NERVE STIMULATION VERSES UNILATERAL SACRAL NERVE STIMULATION IN PTS WHERE UNILATERAL SACRAL NEUROMODULATION FAILS. FIFTEEN PATIENTS (13 FEMALES, 2 MALES) WERE INCLUDED IN THIS STUDY; THEY UNDERWENT TEST STIMULATION WITH PERCUTANEOUS NERVE EVALUATION. REPORTABLE EVENT: THE AUTHORS REPORTED THAT IN 3 PTS, LEAD MIGRATION WAS SUSPECTED AND, THUS, THEY WERE NOT INCLUDED IN ANALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR UNK LEAD