BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3202833 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11231
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 17, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28 LOT# V806858, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE CAUSE OF THE EVENT WAS A SUPERFICIAL INS (IMPLANTABLE NEUROSTIMULATOR) PLACEMENT. THE INS WAS TURNED OFF BY RETAIL STORE SCANNERS. INTERVENTIONS ON 2013 (B)(6) INCLUDED CHANGING OF THE BANDWIDTH AND EVALUATION OF BATTERY LIFE. THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THE EVENT. IT WAS STATED THAT THE INS WENT OFF ON ITS OWN. BATTERY LIFE WAS REASONABLE. THE PATIENT COULD FEEL MUCH BETTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S STIMULATION WAS TURNING OFF. IT WAS NOTED THAT THE PATIENT WAS NOT USING THE PATIENT PROGRAMMER BUT THE STIMULATOR STILL ¿GOT SHUT OFF¿. IT WAS STATED THAT EVERYTHING "APPEARED TO BE FINE" WITH STIMULATOR EXCEPT WHEN THE PATIENT CAME TO SEE HEALTHCARE PROVIDER THE DEVICE WAS OFF. IT WAS NOTED THAT A FOLLOW-UP APPOINTMENT WOULD BE PLANNED FOR TROUBLESHOOTING THE DEVICE. IT WAS LATER REPORTED THAT THE PATIENT WAS BEING SCHEDULED FOR A FOLLOW UP VISIT AND NO DIAGNOSTICS HAVE BEEN PERFORMED YET. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302047 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1