BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3771308 · Received April 24, 2014

    Report

    Report Number
    3004209178-2014-08082
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    April 7, 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 Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA01DYK, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT COMPATIBILITY GUIDELINES WERE REQUESTED FOR DENTAL DRILLS, ULTRASONIC PROBES AND AIRPORT SECURITY SCREENING DEVICES. THE PATIENT REPORTS WHILE STIMULATION WAS TURNED ON, THE FOLLOWING OCCURS, THE PATIENT REPORTS A LOSS OF THERAPEUTIC EFFECT. THE PATIENT WAS DOING GREAT WITH THE TRIAL AND THE FIRST 5 DAYS AFTER IMPLANT. THE PATIENT STATES THIS PAST ONE TO TWO DAYS BEFORE REPORTED EVENT DATE ALL THEIR SYMPTOMS STARTED AGAIN. THE PATIENT DIDN¿T TRY TO CHANGE IT BECAUSE THEY WASN¿T SURE IF THEY SHOULD. THE PATIENT STIMULATION EASED OFF. THE PATIENT STATES THE REPRESENTATIVE HAD PLACED TAPE OVER ON AND OFF SWITCH. THE PATIENT REPORTS ON THE DAY OF REPORTED EVENT DATE THEY THOUGHT IT HAD LEVELED OUT AND THE PATIENT WAS NOT HAVING AS MUCH INCONTINENCE AS OVER THE WEEKEND. THE PATIENT STATES IT COULD BE BECAUSE OF WHAT THEY ATE AND HAS HAD TO TAKE MORE MEDICATIONS THAN THEY NORMALLY WOULD TAKE. THE PATIENT DOESN¿T FEEL THE STIMULATION AS MUCH. THE PATIENT WAS STAYING WITH SON FOR 10 DAYS BEFORE THEY GOES BACK HOME. IT WAS REPORTED THE DAY AFTER SURGERY THE REPRESENTATIVE TOLD TO TURN ON AN INCREASE STIMULATION AND DO ONCE A WEEK EVERY WEEK. THE BOWEL INCONTINENCE WAS DOING GREAT WITH THE TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249380 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR