BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3143409 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08575
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 15, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37085-95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3389S-40, LOT# V386123, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT RECEIVED AN END OF SERVICE (EOS) OR END OF LIFE (EOL) MESSAGE ON THEIR DEVICE. IT WAS STATED THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY DEPLETION WAS REPORTED AS PREMATURE. IT WAS ALSO STATED THE INS WAS GOING TO ¿FAIL¿ BEFORE THE ¿ALLOTTED TIME.¿ IT WAS REPORTED THE PATIENT SAW THE ERROR MESSAGE IN THE MIDDLE OF (B)(6) 2013. IT WAS NOTED THE PATIENT WAS TOLD BY THEIR MANUFACTURER REPRESENTATIVE FOUR WEEKS PRIOR TO REPORT THAT THEY WOULD HAVE TO HAVE THEIR DEVICE REPLACED WITHIN SIX WEEKS. IT WAS ALSO REPORTED THE PATIENT WAS SCHEDULED TO HAVE CHEMOTHERAPY RADIATION ON THE BACK OF THEIR NECK. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243920 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention