BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3111542 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07622
    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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3093-28, LOT# V872545, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A CAR WRECK TWO MONTHS AGO AND STATED 'IT FELT LIKE MY IMPLANT WAS ON FIRE THE DAY I HAD THE WRECK, SO I SHUT THE THING OFF.¿ IT WAS NOTED THAT ¿IT WASN¿T WORKING EVEN BEFORE THE WRECK.¿ THE PATIENT HAD BEEN ABLE TO FEEL STIMULATION, BUT WAS NOT GETTING SYMPTOM RELIEF. IT WAS INDICATED THAT THE DEVICE ¿DOESN¿T SEEM TO WORK.¿ AFTER THE WRECK, THE PATIENT WAS WORRIED ABOUT HER IMPLANT SO SHE TURNED IT OFF IN CASE THE ACCIDENT ¿KNOCKED IT LOOSE.¿ SUPPLEMENTAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SEEN BY HER PHYSICIAN TWO WEEKS AGO. IT WAS NOTED THAT THE PATIENT HAD NO COMPLAINTS, THAT THE UNIT WAS OFF, AND THAT THE PATIENT WAS VOIDING WELL. THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND PATIENT OUTCOME WAS REPORTED AS NO INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND WHEN RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213084 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1