BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1890246 · Received October 22, 2010

    Report

    Report Number
    3007566237-2010-08324
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    January 1, 2010
    Report Date
    September 27, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PT EXPERIENCED A SHOCKING/JOLTING SENSATION. THE PT HAD FELL AND LANDED ON HER RECENTLY REPLACED IMPLANTED PULSE GENERATOR. IT WAS NOTED THAT THE PT HAD FELT PAINFUL STIMULATION IN THE "BICYCLE SEAT" AREA, WHEN THE DEVICE WAS INTERROGATED POST-OPERATIVELY. THE PT STILL NEEDED PROGRAMMING ADJUSTMENTS, HOWEVER, A COMPANY REP WAS CONCERNED ABOUT SHOCKING THE PT AGAIN USING A MODEL 8840 PROGRAMMER FOR INTERROGATION PURPOSES. IT WAS NOTED THAT THE PT PROGRAMMER COULD BE USED FOR INTERROGATION WITHOUT INCIDENT. IT WAS INDICATED THAT STIMULATION IS NOT TURNED ON DURING INTERROGATION, BUT THERE IS SOME CURRENT FLOW DUE TO THE TELEMETRY THAT IS GOING ON BETWEEN DEVICES. THE PT'S OUTCOME WAS NOT REPORTED. ADDITIONAL INFO IS BEING REQUESTED, AND WILL BE PROVIDED IN A F/U REPORT AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC NEUROMODULATION 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| IMPLANTED:| EXPLANTED:| LOT# UNK| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8840, LOT# UNK| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# UNK| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL IPG URO| IMPLANTED:| LEAD: MODEL LEAD URO, LOT# UNK