BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3871247 · Received June 13, 2014

    Report

    Report Number
    3007566237-2014-01630
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    May 24, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_LEAD; LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NOTED NO STIMULATION SENSATION. THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT THE STIM STOPPED LAST NIGHT AND THE PATIENT HAD A RETURN OF SYMPTOMS. THE TRIAL WAS DONE TO HELP BLADDER INCONTINENCE. THE PATIENT SAW A GREEN LIGHT BLINKING AND SHE HAD TRIED TURNING STIM UP TO 10 BUT SHE FELT NOTHING. THE PATIENT HAD TRIED SWITCHING SIDES THIS MORNING AS WELL AND TURNING IT UP AND AGAIN, FELT NOTHING. THE PATIENT CONFIRMED THE PLUG WAS FACING UP WHEN PLUGGED INTO SCREENER BOX. THE PATIENT WAS EXPECTING A CALL FROM THE MANUFACTURER'S REPRESENTATIVE. THE PATIENT HAD ALREADY SPOKE TO HCP (HEALTH CARE PROVIDER) LAST NIGHT AND SHE THOUGHT IT COULD ONLY BE THE BATTERY OR THE WIRE ITSELF. ADDITIONAL INFORMATION RECEIVED NOTED THAT REGARDING ANY DEVICE ISSUES SEEN, IT WAS NOTED: LEAD MIGRATIONS. REGARDING ACTIONS WHICH WERE NEEDED, IT WAS NOTED: SWITCHED SIDES. REGARDING IF THE PATIENT WOULD GO ONTO IMPLANT, IT WAS NOTED: THEY DIDN'T KNOW YET. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351101 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3625

    Patients

    Seq Age Sex Outcome Treatment
    1