BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3961555 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-13596
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 8, 2014
    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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3387-40, LOT# J0519663V, IMPLANTED: 2005 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: 2005 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: 2005 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3387-40, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD A BATTERY REPLACEMENT 5 DAYS PRIOR TO REPORT AND THEIR BODY ¿HAD NOT BEEN HAPPY SINCE THE ANESTHESIA WORE OFF AFTER THAT SURGERY¿ AND THEY HAD BEEN ¿TWISTING.¿ THEIR BODY WAS ¿HAPPY¿ AT 2.37V WHEN THE BATTERY WAS REPLACED. IT WAS FURTHER REPORTED IT SEEMED THAT THE PATIENT WAS SET ¿TOO HIGH ON THE NEW BATTERY.¿ THE PATIENT WAS GOING TO TURN THEIR DEVICE DOWN AND FOLLOW UP WITH NEUROLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437629 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR