BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4102927 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17407
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 26, 2014
    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 MEDICAL PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3391S-40, LOT# V591640, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION; PRODUCT ID 3391S-40, LOT# V597842, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION; PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS AN ALZHEIMER¿S RESEARCH PATIENT. THE PATIENT¿S PREVIOUS DEVICE LASTED ELEVEN MONTHS AND THE SHE HAD NO ISSUES WITH IT, EXCEPT THE SETTINGS WERE ¿PLAYED¿ WITH TOWARDS THE END BEING AN EXPERIMENTAL IMPLANT. HOWEVER, THE PATIENT¿S CURRENT IMPLANT WAS PUT IN SIX MONTHS AGO AND WAS FOUND TO BE DOWN TO 2.60 VOLTS ON THE DAY OF THE REPORT. THE REPORTER WANTED TO KNOW IF THIS WAS EXPECTED, SO AN ESTIMATE WAS RUN AND THE LONGEVITY WAS ACCURATE. THE DEPLETION WAS CONSIDERED NORMAL AS THE PATIENT¿S SETTINGS WERE QUITE HIGH. THE PROBLEM WAS THAT THE REPORTER DID NOT SEE AN ELECTIVE REPLACEMENT INDICATOR (ERI), EVEN THOUGH IT WOULD BE EXPECTED. NO FURTHER TROUBLESHOOTING WAS DONE, BUT THE PATIENT WAS SUPPOSED TO CHECK THE BATTERY DAILY WHILE BEING SCHEDULED FOR A REPLACEMENT. THE CAUSE OF THE ISSUE WAS NOT DETERMINED, BUT IT WAS DEVICE RELATED. THE PATIENT WAS DOING FINE AND RECEIVING THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584218 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1