BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3953953 · Received July 23, 2014

    Report

    Report Number
    3004209178-2014-13463
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    June 30, 2014
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-33, LOT# V048838, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3889-33, LOT# V048838, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE CALLER STATED THAT 4-5 YEARS AGO THE PATIENT MENTIONED THAT THE DEVICE WASN'T WORKING AND WAS DISCUSSING REMOVING INS (STIMULATOR). CALLER SAID DUE TO AGE OF THE PATIENT, THE INS WASN'T REMOVED AND MEDICAL NOTES SHOW THE PATIENT WOULD TURN INS OFF IN 2012. COMPATIBILITY GUIDELINES WERE REQUESTED FOR THE PACEMAKERS. CALLER WAS TRYING TO RULE IN OR OUT POSSIBLE DEVICE INTERACTION. THE PATIENT BELIEVES STIMULATOR WAS TURNED OFF BUT PATIENT PROGRAMMER LOCATION WAS UNKNOWN SO CALLER CANNOT CHECK DEVICE STATUS. CALLER ASKED IF THERE WAS ANY OTHER WAY TO TELL IF INS WAS OFF. CALLER INQUIRING IF THE INS BATTERY MAY BE DEAD. IT WAS NOTED THAT THE PATIENT WAS MEETING WITH THE CARDIO HCP (HEALTHCARE PROVIDER) AND REPRESENTATIVE THE DAY AFTER REPORTED EVENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431343 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR