BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2351386 · Received November 29, 2011

    Report

    Report Number
    3004209178-2011-09459
    Event Type
    Malfunction
    Date Received
    November 29, 2011
    Report Date
    November 29, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3889-28 LOT #V244043 IMPLANTED: (B)(6) 2009 EXPLANTED: UNK; PROGRAMMER MODEL 3037 SERIAL # (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION. THE DEVICE WAS ADJUSTED WITH THE PROGRAMMER, AND THE PATIENT REGAINED CONSISTENT STIMULATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FROM THE IMPLANTABLE NEUROSTIMULATOR (INS) THE NIGHT AFTER REPLACEMENT SURGERY. OVERNIGHT THE PATIENT EXPERIENCED A CONSIDERABLE AMOUNT OF LEAKAGE AND THE NEXT DAY COULD ONLY FEEL STIMULATION IN THE LABIA. PRIOR TO THE REPLACEMENT THE PATIENT FELT STIMULATION IN THE LABIA AND RECTUM. IN ADDITION, THE PATIENT'S STIMULATION SENSATION WAS INTERMITTENT, WHICH WAS NOT THE CASE PRIOR TO THE INS REPLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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