BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA RC

    MDR report key: 2147393 · Received June 8, 2011

    Report

    Report Number
    3007566237-2011-04160
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 11, 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, CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3389-28 LOT# 0203095937 IMPLANTED: UNKNOWN EXPLANTED: NA; LEAD MODEL 3389-28 LOT # 0203497491 IMPLANTED: UNKNOWN EXPLANTED: NA; EXTENSION MODEL 37085-60 (B)(4) IMPLANTED: UNKNOWN EXPLANTED: NA; EXTENSION MODEL 37085-60 (B)(4) IMPLANTED: UNKNOWN EXPLANTED: NA; THE INITIAL MDR WAS FILED AS MFR. REPORT # 3007566237-2011-04160. ADDITIONAL REVIEW INDICATED THE CORRECT MANUFACTURING SITE WAS SITE # 3004209178.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED THAT THE PATIENT HAD PARKINSON'S DISEASE SINCE 2002. BEFORE THE SURGERY SHE HAD DISABLING RESTING TREMOR AND OFF PERIODS DURING WHICH SHE EXPERIENCED TREMOR INSIDE, SLOW WALKING, AND GENERAL SLOWNESS. FOLLOWING THE SURGERY THE PATIENT HAD A SIGNIFICANT DECREASE IN TREMOR AND INCREASED DIFFICULTY WALKING, WITH FREEZING AND DECREASED BALANCE. THE FALLING WAS SECONDARY TO THE FREEZING. THE PATIENT'S BALANCE ISSUES SAW SOME IMPROVEMENT WITH LOW FREQUENCY STIMULATION. IT WAS NOTED THAT THE STIMULUS SITE IN THE BRAIN WAS AT THE BILATERAL SUBTHALMIC NUCLEUS. ONE LEAD WAS PROGRAMMED TO C+/1-, AT 6.5 VOLTS, A PULSE WIDTH OF 60 MICROSECONDS, AND A FREQUENCY OF 60 HZ. THE OTHER LEAD WAS PROGRAMMED TO C+/10-, AT 6.5 VOLTS, A PULSE WIDTH OF 60 MICROSECONDS, AND A FREQUENCY OF 60 HZ.

    Description of Event or Problem · 1

    A MFR'S REP MEASURED HIGH IMPEDANCES ON THE PT'S IMPLANTABLE NEUROSTIMULATOR (INS). THE IMPEDANCES WERE C0=2126, C1=1733, C2=1989, C3=1712, 0-1=3343, 02=4269, 03=4031, 12=3226, 13=3126, 23=3388. THE PT HAD BEEN FALLING MORE OFTEN SINCE RECEIVING THE INS. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA RC STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 37612 NA

    Patients

    Seq Age Sex Outcome Treatment
    1