BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3370864 · Received September 26, 2013

    Report

    Report Number
    3004209178-2013-17006
    Event Type
    Malfunction
    Date Received
    September 26, 2013
    Report Date
    September 5, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37651, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37085-40, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-40, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT # V911922, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT # V931137, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STIMULATION WAS TURNING OFF AND THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT THE PATIENT HAD DYSTONIA AND IT WOULD TAKE ¿A WHILE¿ TO NOTICE THE RETURN OF SYMPTOMS. IT WAS FURTHER NOTED THAT THE PATIENT WAS IMPLANTED IN THE MONTH OF APRIL PRIOR TO THE DATE OF THE REPORT. THE PATIENT REPORTEDLY NOTICED IN THE AUGUST PRIOR TO THE DATE OF THE REPORT THAT THEIR SYMPTOMS WERE WORSE. IT WAS NOTED THAT THE PATIENT WAS RECHARGING ¿EVERY COUPLE OF DAYS.¿ THE PATIENT REPORTEDLY SAW THEIR NEUROLOGIST AND TOLD HIM THAT THEIR SYMPTOMS WERE WORSE AND THE DOCTOR NOTED THAT STIMULATION WAS OFF. IT WAS NOTED THAT THE PATIENT WAS ADJUSTED ON THE PRIOR FRIDAY AND THE WEDNESDAY BEFORE IT ¿WAS OFF.¿ IT WAS ALSO NOTED THAT IT ¿TURNED EVERY DAY IN SEPTEMBER AND THE LAST FOUR DAYS OF AUGUST ,¿ IT WAS UNCLEAR WHAT THIS MEANT. IT WAS LATER REPORTED THAT AFTER INTERROGATION OF THE DEVICE IT COULD NOT BE DETERMINED IF THERE WERE ANY MALFUNCTIONS. IT WAS NOTED THAT NONE WERE SEEN AND NO CAUSE OF THE ISSUE WAS DETERMINED. THE PATIENT WAS INSTRUCTED TO ROUTINELY CHECK IF THE DEVICE WAS ON AND IF IT TURNED OFF TO COME BACK INTO THE OFFICE. IT WAS NOTED THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY ON THE DAY OF THE REPORT. IT WAS LATER REPORTED THAT THE PATIENT WAS SEEN BY THEIR DOCTOR BECAUSE THE DEVICE SHUT OFF AGAIN. IT WAS LATER REPORTED THAT THE CLINICIAN PROGRAMMER REPORT SHOWED THAT THE DEVICE WAS OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487953 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR