BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2354843 · Received December 1, 2011

    Report

    Report Number
    3004209178-2011-09520
    Event Type
    Injury
    Date Received
    December 1, 2011
    Date of Event
    October 21, 2011
    Report Date
    November 17, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3387S-40, LOT # V055961, IMPLANTED: (B)(6) 2007, EXPLANTED: UNKNOWN; LEAD MODEL 3387S-40, LOT # V050681, IMPLANTED: (B)(6) 2007, EXPLANTED: UNKNOWN; EXTENSION MODEL 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: UNKNOWN; EXTENSION MODEL 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: UNKNOWN; PROGRAMMER MODEL 37642, SERIAL # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION EVERY TEN MINUTES AT THE IMPLANTABLE NEUROSTIMULATOR POCKET SITE AND BEHIND THE EAR AT THE LEAD / EXTENSION SITE. THE SENSATION BEGAN THE DAY AFTER IMPLANT. THE THERAPY WAS OTHERWISE WORKING WELL FOR THE SYMPTOMS. IMPEDANCE MEASUREMENTS AND THERAPY IMPEDANCE WERE WITHIN NORMAL RANGE. X-RAYS WERE TAKEN, BUT THE RESULTS WERE NOT KNOWN. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD BEEN REPROGRAMMED MANY TIMES WITHOUT ANY CHANGE. A SURGICAL INTERVENTION WAS PERFORMED TO SWITCH OUT THE 2X4 ADAPTOR. AS FAR AS THE MANUFACTURER REPRESENTATIVE KNEW, THE PATIENT WAS DOING FINE AND THE SHOCKING ISSUE HAD BEEN RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention