BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3111874 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07631
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 24, 2013
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V933653, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LAST (B)(6) THE PATIENT NOTICED THAT WHEN HE WENT IN AND OUT OF THE STORE "A FEW TIMES" HIS SYMPTOMS STARTED TO COME BACK THE NEXT DAY. THE PATIENT TURNED THE IMPLANT OFF AND THE ON AND NOTICED SYMPTOM RELIEF. IT WAS ALSO REPORTED THAT WHEN THE PATIENT WENT THROUGH SECURITY GATES AT THE STORE HE GOT A "STRONG JOLT" THAT MADE HIS "LEG JUMP." THE PATIENT ALSO FELT PAIN IN THE IMPLANT AREA WHEN HE MOVED OR STRETCHED. THE PATIENT STATED THAT THIS WAS NOT "ALL THE TIME BUT EVERY ONCE IN A WHILE." AT THE TIME OF THE REPORT THE PATIENT'S DEVICE WORKED GREAT AND HELPED WITH HIS SYMPTOMS. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD NO CONCERNS REGARDING THEIR DEVICE/THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212699 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR