BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3960042 · Received July 28, 2014

    Report

    Report Number
    3007566237-2014-02085
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN THOUGHT THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY ¿LASTED LESS¿ THAN A DIFFERENT MODEL THE MANUFACTURER PRODUCED. IT WAS FURTHER REPORTED THEY THOUGHT THIS WAS ¿MORE EVIDENT WHEN THE POCKET ADAPTOR WAS NECESSARY.¿ IT WAS STATED THE INS HAD UNDERGONE ¿PREMATURE¿ BATTERY DEPLETION AND WAS REPLACED AS A RESULT. IT WAS NOTED THE EVENT WAS A ¿GENERAL COMMENT¿ REPORTED BY THE PHYSICIAN. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437569 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention