BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACTIVA

    MDR report key: 1013086 · Received March 14, 2008

    Report

    Report Number
    MW5005857
    Event Type
    Other
    Date Received
    March 14, 2008
    Report Date
    March 14, 2008
    Manufacturer
    MEDTRONIC
    Product Code
    MHY
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT STATED THAT ON THE FIRST BATTERY, SHE WAS TOLD IT WILL LAST 3-5 YEARS, BUT IT ONLY LASTED 15 MONTHS AND THEY HAD TO REPLACE IT ON MARCH 2007. ON THE SECOND BATTERY, THEY TUNED HER BATTERY UP TO 6 VOLTS, THE HIGHEST LEVEL WHICH CAUSED HER SPEECH PROBLEM. SHE CAN HARDLY KEEP OPEN EYELIDS AND HER TREMORS HAS BEEN INCREASED. SHE THEN WENT TO ANOTHER DR AND THEY TURNED HER BATTERY COMPLETELY OFF. THEN TUNED IT UP TO 2.5 AND 3.5 GRADUALLY. HER SPEECH BACKED TO NORMAL, BUT STILL IS EXPERIENCING TREMORS AND HER EYELIDS PROBLEM. SHE ALSO HAD ONE EPISODE OF FALLING BEFORE THE REPLACEMENT. PATIENT STATED THAT THE PAPER WORK SENT TO THE DR INDICATED THE FIRST BATTERY WAS FINE. SHE BELIEVED THAT THE OLD FIRST BATTERY NEVER GOT BACK TO MEDTRONIC FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA NONE MHY MEDTRONIC 7428
    2 ACTIVA NONE MHY METRONIC 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR