BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2873776 · Received December 14, 2012

    Report

    Report Number
    3004209178-2012-11830
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Report Date
    November 26, 2012
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT# V952169, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3093-28, LOT# V952169, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION WAS INTERMITTENT. WHEN THE PATIENT FIRST GOT THE DEVICE, THE PATIENT HAD INTERMITTENT STIMULATION AND SHOCKS WHEN THEY WENT THROUGH SECURITY DEVICES. IT WAS ALSO NOTED SOME SECURITY DEVICES WOULD TURN THE IMPLANTABLE NEUROSTIMULATOR (INS) OFF AND PATIENT WOULD GET SEVERE DIARRHEA AND BARELY MAKE IT OUT OF THE STORE.

    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