BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2061797 · Received March 30, 2011

    Report

    Report Number
    3004209178-2011-02419
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 22, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE STIMULATION WAS TURNED ON, THERE NO STIMULATION SENSATION. THE PT HAD NOT FELT STIMULATION IN ABOUT 4 DAYS. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT. A HIGH IMPEDANCE WAS NOTED: READING >4000 OHMS ON ALL OF THE BIPOLAR PAIRS EXCEPT FOR ELECTRODE COMBOS 0 AND 1, 2 AND 3, AND 1 AND 2. ADDITIONAL INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT # NJD024122N| LEAD: MODEL 3889, LOT # V009058| EXPLANTED:| EXTENSION: MODEL 3095, LOT # NAH031811V| IMPLANTED: