BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2438510 · Received February 3, 2012

    Report

    Report Number
    3004209178-2012-00766
    Event Type
    Malfunction
    Date Received
    February 3, 2012
    Report Date
    January 9, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 3889-28, LOT# V161679, IMPLANTED: 2008 (B)(6), EXPLANTED: UNK. PROGRAMMER: MODEL 3037, SERIAL# (B)(4).

    Description of Event or Problem · 1

    THE "LEAD # 3" WAS BROKEN. IT WAS UNKNOWN HOW IT HAPPENED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1