BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2062428 · Received April 12, 2011

    Report

    Report Number
    3004209178-2011-02746
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A POWER-ON-RESET (POR) CONDITION WAS REPORTED ON THE PT'S NEUROSTIMULATOR AND SHE COULD NOT ADJUST THEIR STIMULATION FOLLOWING RIGHT HIP REPLACEMENT SURGERY. IT WAS NOTED THAT THE STIMULATION WAS TURNED OFF PRIOR TO THE SURGERY. ADD'L INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR PROGRAMMER: MODEL 3037, LOT# NJD085714N| LEAD: MODEL 3093, LOT# V243906| IMPLANTED:| EXPLANTED: