BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5192260 · Received October 30, 2015

    Report

    Report Number
    3004209178-2015-21926
    Event Type
    Injury
    Date Received
    October 30, 2015
    Report Date
    October 8, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    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 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT REPORTED THERE WAS A 573 ERROR CODE. THE MESSAGE HAD OCCURRED TWICE AND THE PATIENT REPLACED THE BATTERIES IN THE PATIENT PROGRAMMER (PP) AND THE ISSUE WAS RESOLVED. THE PATIENT WAS NOT GETTING THE BATTERY CHARGED TO THE SPRITES. THEY FELT THE BATTERY WASN'T HOLDING A CHARGE LIKE IT USED TO. THE PATIENT WAS IMPLANTED FOR DYSTONIA. ADDITIONAL INFORMATION RECEIVED 5 DAYS LATER REPORTED THE DEVICE WAS CHARGING ADEQUATELY DESPITE THE FACT THAT HER CERVICAL COLLAR WAS HINDERING HER ABILITY TO POSITION THE RECHARGE ANTENNA IN ITS MOST EFFICIENT POSITION. NO OTHER INTERVENTIONS WERE PLANNED. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT 4 DAYS LATER REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO A FALL SHE HAD WHICH RESULTED IN SEVERAL KNOTS ON HER HEAD. DUE TO THE FALL, THE PATIENT "CAME TO ENOUGH" TO REALIZE THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY HAD DEPLETED AND SHE NEEDED TO RECHARGE. DUE TO THE BATTERY DEPLETION, THE THERAPY SHUT ITSELF OFF. THEY WERE ABLE TO RECHARGE THE INS TO 25% BUT COULD NOT TURN THE STIMULATION ON BECAUSE SHE DIDN'T HAVE THE PATIENT PROGRAMMER. THE INS BATTERY LEVEL WAS STILL TOO LOW TO USE THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) TO TURN THE STIMULATION ON. THEY WEREN'T ABLE TO TURN THE STIMULATION BACK ON YET. THE PATIENT WAS ADVISED TO CHARGE TO 50% AND THEN ATTEMPT TO TURN THE INS ON USING THE INSR. ADDITIONAL INFORMATION RECEIVED 3 DAYS LATER FROM THE PATIENT REPORTED THERE WAS A 376 INSR ANTENNA TEMPERATURE FAILURE CODE. THERE WAS ALSO A 375 ERROR CODE (CHARGE CURRENT LOW) ON THE RECHARGER. THERE WAS A DAMAGED RECHARGING ANTENNA. THE PATIENT'S INS WAS CHARGED TO 50% BUT THE INS HAD DIED SO HER STIMULATION WAS STILL OFF. THE PATIENT WAS "OUT OF IT" FOR A COUPLE OF DAYS BUT WAS NOT UNCONSCIOUS SINCE THE FALL. PATIENT WAS ONLY GETTING 2-4 COUPLING BOXES BUT THEY WEREN'T TRYING TO CHARGE DURING THE CALL. THEY WERE UNSUCCESSFUL IN TRYING TO TURN THE INS ON WITH THE INSR. SHE WAS HAVING TROUBLE WITH HER HANDS BUT IT HAD NOTHING TO DO WITH THE DYSTONIA. THEY WERE ABLE TO TURN THE INS ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722676 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization