BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 2050057 · Received March 31, 2011

    Report

    Report Number
    3004209178-2011-02470
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 4, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS IN A CAR ACCIDENT ON (B)(6) 2010, 6 DAYS AFTER A VERY SUCCESSFUL PROGRAMMING SESSION. THE PT SUSTAINED NO INJURIES IN THE ACCIDENT. IN (B)(6) 2011, THE PT MOVED AND BEGAN TO FEEL A DECLINE IN THERAPY AND A LOSS OF THERAPEUTIC EFFECT. FOLLOWING AN ASSESSMENT, THE RIGHT SIDE APPEARED TO BE WORSE THAN THE LEFT SIDE. IN (B)(6) 2011, THE PT WAS REPROGRAMMED BY THE HEALTHCARE PROVIDER (HCP). WHEN THE HCP ATTEMPTED TO PROGRAM THE RIGHT LEAD (RIGHT HEMISPHERE), SHE NOTED A SIGNIFICANT IPSILATERAL EFFECT FROM TIME TO TIME. THE HCP REPORTED NO ONE ELSE COULD HAVE SWITCHED LEAD NUMBERING AS SHE WAS THE ONLY ONE WHO PROGRAMMED THE PT. IT WAS ALSO NOTED THAT MOVEMENT DID NOT CAUSE STIMULATION CHANGES. IMPEDANCE READINGS WERE WITHIN NORMAL RANGES. ADD'L INFO HAS BEEN REQUESTED; A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    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 38 YR IMPLANTED:| PROGRAMMER: MODEL 37642, LOT# NJZ104063N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3389S-40, LOT# V455934| EXPLANTED:| LEAD: MODEL 3389S-40, LOT# V427154| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN008183V| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN008096V