BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA SC

    MDR report key: 2210312 · Received August 9, 2011

    Report

    Report Number
    3004209178-2011-06165
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 1, 2011
    Report Date
    October 31, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE NEUROSTIMULATOR FOUND NO ANOMALIES. THE LONG TERM MONITOR INDICATED THE INS FUNCTIONED PROPERLY. THE CONNECTOR BLOCK LEAKAGE TEST FOUND NORMAL IMPEDANCES. THE TRACE REPORT WAS OK, AND FOUND THE BATTERY AT 3.04 VOLTS. THE INSULATION COATING, INS CAN, SETSCREWS, GROMMETS, CONNECTOR MODULES AND ACCESS HOLE ADHESIVE WERE OK. THE CONNECTOR PORTS HAD FOREIGN MATERIAL IN THE PORTS. THE TELEMETRY WAS OK, THERE WAS GOOD STABLE OUTPUT ON ALL ELECTRODE PAIRS. THERE WAS GOOD STABLE OUTPUT ON ALL ELECTRODE PAIRS AS RECEIVED. THERE WERE NO PROBLEMS WHEN PRESSING ON THE INS CAN. ANALYSIS OF THE EXTENSION FOUND NO ANOMALY. THE PROXIMAL END OF THE EXTENSION WAS OK. THERE WERE SETSCREW MARKS IN THE CORRECT LOCATION. THE CONDUCTORS, CRIMP SLEEVE AND OUTER INSULATION WERE OK. THE DISTAL END WAS OK. CONTINUITY WAS ACCEPTABLE AND THERE WERE NO SHORTS BETWEEN CIRCUITS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING A SHOCKING SENSATION AND "SHARP" PARESTHESIA AS WELL AS INTERMITTENT LOSS OF THERAPEUTIC EFFECT AFTER IMPLANT. THERAPY RETURNED UPON PALPATION, HOWEVER, ONCE PRESSURE WAS RELEASED, THE THERAPY WENT AWAY AND THE PATIENT FELT VERY STRONG PARESTHESIA. THE PHYSICIAN BELIEVED THAT EITHER THE EXTENSION OR THE NEUROSTIMULATOR WAS FAULTY; THEREFORE, BOTH WERE EXPLANTED AND REPLACED. THE CAUSE OF THE EVENT WAS UNKNOWN, ALTHOUGH IT WAS SUSPECTED THE EXTENSION MAY HAVE BEEN FRACTURED OR DAMAGED. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA SC STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 37602 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention PROGRAMMER: MODEL 37642, LOT # NJZ112368N| EXTENSION: MODEL 7482A, LOT # NHU174878V| EXPLANTED:| IMPLANTED:| LOT # NFW147560H| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387S, LOT # V111315| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| EXPLANTED: