BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3926420 · Received July 10, 2014

    Report

    Report Number
    3007566237-2014-01923
    Event Type
    Injury
    Date Received
    July 10, 2014
    Report Date
    June 18, 2014
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECENTLY HAD A REVISION PERFORMED BECAUSE THEIR IMPLANTABLE NEUROSTIMULATOR (INS) ¿WAS NOT WORKING PROPERLY¿. IT WAS REPORTED THAT THE PATIENT WAS TO HAVE RF SPINAL ABLATION (USING A STRYKER SYSTEM) ON THE SAME SIDE AS THEIR INS. IT WAS NOTED THAT THE PATIENT DID HAVE RF ABLATION ON THE OTHER SIDE OF THE SPINE BUT ¿NOT ON THE SAME SIDE¿ AND IT WAS REPORTED THAT THERE WERE NO PROBLEMS. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403993 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention