BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 2211122 · Received August 8, 2011

    Report

    Report Number
    3004209178-2011-06156
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    June 1, 2011
    Report Date
    October 12, 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
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED THAT THE CAUSE OF THE EVENT WAS A CHANGE IN THE PATIENT'S MEDICATION (ADDED COMTAN TO SINEMET). IT WAS UNLIKELY THAT ANY PART OF THE DEEP BRAIN STIMULATION SYSTEM WAS AN ISSUE. THE ELECTRODE (#2) WITH THE HIGH IMPEDANCES WAS NOT BEING USED IN THE THERAPY, BUT DID PRODUCE SIDE EFFECTS (ARM PAIN, DIFFICULTY SPEAKING, AND FACIAL PULLING) WHEN TESTED. AS OF THE LAST VISIT, THE PATIENT WAS DOING WELL WITH THE STIMULATION PROGRAM AND MEDICATION. THE PATIENT DID REQUIRE AND ER VISIT AND A CT SCAN OF THE HEAD FOLLOWING THE FALL, BUT DID NOT REQUIRE AN EXTENDED STAY ADMISSION. THE PATIENT RECOVERED WITHOUT SEQUELAE. THE HCP NOTED THAT THE LEFT STIMULATION PROGRAM WAS CONTROLLING THE LEFT SIDE OF THE BODY, AND THE RIGHT STIMULATION PROGRAM WAS CONTROLLING THE RIGHT SIDE OF THE BODY, EVEN THOUGH THE LEAD CONFIGURATION WAS APPROPRIATELY SET UP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALL COMBINATIONS WITH #2 ARE >40000 OHMS. A LOSS OF THERAPEUTIC EFFECT WAS REPORTED. PATIENT REPORTED THEY MAY STILL BE GETTING SOME STIMULATION BENEFIT. THE PATIENT FELL TWO WEEKS AGO AND HIT HIS HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU153590V| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387S, LOT# V107750| EXTENSION: MODEL 7482, LOT# NHU153589V| PROGRAMMER: MODEL 37642, LOT# NJZ106931N| ADAPTER: MODEL 64002, LOT# N248399| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3387S, LOT# V107750| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED: