BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA RC

    MDR report key: 2223798 · Received August 18, 2011

    Report

    Report Number
    3007566237-2011-06510
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    March 25, 2011
    Report Date
    July 29, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANTATION THE HOSPITAL COULD NOT ACHIEVE ANY BLACK BOXES ON THE COUPLING SCALE, THOUGH THEY COULD INTERROGATE THE DEVICE. TWO WEEKS LATER THE PT RETURNED FOR PROGRAMMING AND THE DEVICE WAS AT 50% CHARGE, AND THE HOSPITAL WAS STILL UNABLE TO OBTAIN BLACK BOXES UPON COUPLING. THE PT CONFIRMED THAT SHE HAD RECHARGED ON ALTERNATE DAYS, HOWEVER THERE WAS NO RECHARGE HISTORY ON THE N'VISION. ON (B)(6) 2011, THE DEVICE REACHED DISCHARGE. A PHYSICIAN RECHARGE WITH THE ANTENNA LOCATOR COULD NOT OBTAIN COUPLING. IT WAS REPORTED THAT POST-OP IT WAS SUSPECTED THE DEVICE WAS IMPLANTED TOO DEEPLY. THE PT HAD THE DEVICE EXPLANTED AND REIMPLANTED. ONE OF THE EXTENSIONS WAS OVER THE FRONT RIGHT CORNER OF THE IMPLANTABLE PULSE GENERATOR AND THE DEVICE WAS IMPLANTED QUITE DEEP. AFTER REIMPLANTATION, THE DEVICE COULD BE CHARGED. THERE WAS NO OVERDISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA RC STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37612 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention