BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3904538 · Received July 1, 2014

    Report

    Report Number
    3007566237-2014-01831
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Report Date
    June 9, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRIAL PATIENT DIDN¿T FEEL THE STIMULATION CURRENTLY AND THE PATIENT HAD ALZHEIMER¿S AND DEMENTIA. THE TRIAL HAD BEEN GOING ON FOR 3 WEEKS AND DURING THE FIRST WEEK THE PATIENT HAD TO FORCE URINE OUT EVEN THOUGH THEIR PROBLEM WAS URGENCY AND FREQUENCY. IT WAS NOTED THAT THE PATIENT NO LONGER HAD TO FORCE URINE OUT AND THE ISSUE SEEMED TO BE RESOLVED. THE PATIENT KNEW THE THERAPY WAS WORKING TO RELIEVE SOME OF THE URGENCY AND FREQUENCY ISSUES BUT THEY WERE CONCERNED THAT THEY DIDN¿T FEEL STIMULATION. IT WAS REPORTED THAT THEY TURNED THE AMPLITUDE UP TO 6V FROM 3V OVER THE WEEKEND AND THE PATIENT STILL DID NOT FEEL THE STIMULATION. THE PATIENT ALSO HAD A PIECE OF SILVER WIRE STICKING OUT FROM THEIR BACK THAT WAS NOT PRESENT BEFORE. IT WAS NOTED THAT THE ISSUE WAS UNRESOLVED AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383008 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3625

    Patients

    Seq Age Sex Outcome Treatment
    1