BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3459675 · Received November 8, 2013

    Report

    Report Number
    3004209178-2013-20498
    Event Type
    Malfunction
    Date Received
    November 8, 2013
    Date of Event
    October 21, 2013
    Report Date
    October 21, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V043266, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# V043266, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A POWER ON RESET (POR) CONDITION WITH A 0400 ERROR CODE. IT WAS REPORTED THAT DURING THE DAY PRIOR TO REPORT THE PATIENT ¿WAS IN THE KITCHEN CUTTING CHICKEN NEXT TO THE MICROWAVE¿ AND ¿FOLLOWING THIS WAS NOT FEELING WELL.¿ IT WAS FURTHER REPORTED THE PATIENT VISITED THE EMERGENCY ROOM (ER) THE NIGHT PRIOR TO REPORT DUE TO NOT FEELING WELL. IT WAS UNKNOWN WHETHER THE POR MESSAGE WAS DISPLAYED BEFORE OR AFTER GOING TO THE ER. A MANUFACTURER REPRESENTATIVE WAS REPORTED TO HAVE BEEN ABLE TO CLEAR THE POR CONDITION USING A PHYSICIAN PROGRAMMER AT THE ER. IT WAS STATED THAT WHEN THE PATIENT¿S IMPLANT WAS TURNED BACK ON, THE PATIENT WAS ¿FEELING STIMULATION AND STARTED FEELING BETTER.¿ IT WAS NOTED THE PATIENT¿S FAMILY DID NOT MENTION ANY POR MESSAGES BEFORE THE DAY PRIOR TO REPORT AND THAT THE PATIENT¿S ¿DAUGHTER WAS PRESSING A LOT OF BUTTONS ON THE PATIENT PROGRAMMER.¿ ADDITIONAL INFORMATION REPORTED AN INTERROGATION OF THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) TOOK PLACE ON THE DAY OF REPORT. IT WAS STATED THE PATIENT¿S ¿SETTINGS REMAINED THE SAME.¿ IT WAS RESTATED THAT THE PATIENT ¿FELT THE STIMULATION COME BACK ON¿ AND THE PATIENT WAS ¿FEELING BETTER ALREADY¿ THREE DAYS AFTER THE INITIAL REPORT. IMPEDANCE TESTING ON THE PATIENT¿S LEFT AND RIGHT LEADS REVEALED ¿NO HIGH/LOW IMPEDANCES¿ AND THAT THE IMPEDANCES WERE ¿OK.¿ IT WAS STATED THE CAUSE OF THE POR WAS NOT DETERMINED AND THERE WERE ¿NO¿ MALFUNCTIONS SEEN. NO INTERVENTIONS WERE REPORTED TO HAVE BEEN PLANNED. IT WAS NOTED THE PATIENT WAS TO MONITOR THEIR CONDITION AND REPORT ANY ADDITIONAL POR CONDITIONS. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580378 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR