BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 2193622 · Received July 14, 2011

    Report

    Report Number
    3004209178-2011-05451
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    December 9, 2009
    Report Date
    June 21, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED THERAPY FROM A BONE GROWTH STIMULATOR AFTER BREAKING HIS WRIST. THE PATIENT DID NOT HAVE ANY ADVERSE EVENTS FOLLOWING USE OF THE BONE GROWTH STIMULATOR. THE PATIENT HAD EXPERIENCED WORSENING GAIT AND DYSARTHRIA; HOWEVER THIS WAS PRIOR TO USING THE BONE GROWTH STIMULATOR. SYMPTOMS IMPROVED AFTER REPROGRAMMING THE PULSE WIDTH. AN OPEN CIRCUIT ON THE ZERO ELECTRODE ON THE RIGHT SIDE WAS ALSO REPORTED. THE OPEN CIRCUIT OCCURRED AT THE TIME OF IMPLANT DUE TO SCAR TISSUE DAMAGING THE LEAD. THE NEUROSTIMULATOR WAS PROGRAMMED AROUND THE ZERO ELECTRODE, AND THE PATIENT WAS RECEIVING BENEFICIAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR LEAD: MODEL 3387S, LOT# V333236| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LOT# NKM705800H| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN012535V| EXTENSION: MODEL 37085, LOT# NKN005454V| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37601| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387S, LOT# V525542| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37642, LOT# NJZ102830N| EXPLANTED:| LEAD: MODEL 3387S, LOT# V333236| LEAD: MODEL 3387S, LOT# V525542| EXTENSION: MODEL 37085, LOT# NKN004025V| EXTENSION: MODEL 37085, LOT# NKN004026V| IMPLANTED: