BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2595960 · Received June 1, 2012

    Report

    Report Number
    3004209178-2012-03927
    Event Type
    Malfunction
    Date Received
    June 1, 2012
    Report Date
    May 4, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3093-28, LOT# V900974, IMPLANTED: 2012 (B)(6), EXPLANTED: NA, PROGRAMMER MODEL 3037, SERIAL# (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT A LOSS OF EFFECT. IT WAS NOTED THAT THE THERAPY FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WAS WORKING THEN ALL OF A SUDDEN THEY HAD A RETURN OF THEIR SYMPTOMS. SHE NOTIFIED HER PHYSICIAN OF THIS EVENT AND WAS TOLD THAT SHE MIGHT HAVE NERVE DAMAGE SIMILAR TO WHEN SHE HAD A DIFFERENT BLADDER PROCEDURE. SHE ALSO HAD PAIN IN HER LEG BUT THIS WAS PRESENT BEFORE SHE HAD THE INS IMPLANTED. HOWEVER, THE PAIN WAS GETTING PROGRESSIVELY WORSE AND HER PHYSICIAN WANTED TO PERFORM AN MRI TO RULE OUT MULTIPLE SCLEROSIS. SHE WAS GOING TO CONTINUE TO WORK WITH BOTH A SPECIALIST AND HER PHYSICIAN. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention