BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2425694 · Received January 23, 2012

    Report

    Report Number
    3004209178-2012-00449
    Event Type
    Malfunction
    Date Received
    January 23, 2012
    Report Date
    January 4, 2012
    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
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NEUROSTIMULATOR MODEL 37601 (B)(4) IMPLANTED: (B)(6)-2011 EXPLANTED: NA, PROGRAMMER MODEL 37642 (B)(4), EXTENSION MODEL 7482A51 (B)(4) IMPLANTED: (B)(6)-2008 EXPLANTED: NA, ACCESSORY KIT MODEL 3550-09 (B)(4) IMPLANTED: (B)(6)-2008 EXPLANTED: NA, LEAD MODEL 3389S-40 LOT# V130326 IMPLANTED: (B)(6)-2008 EXPLANTED: NA, EXTENSION MODEL 7482A51 (B)(4) IMPLANTED: (B)(6)-2008 EXPLANTED: NA, LEAD MODEL 3389S-40 LOT# V137280 IMPLANTED: (B)(6)-2008 EXPLANTED: NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD LOW IMPEDANCE VALUES ON THEIR IMPLANTABLE NEUROSTIMULATOR (INS). C,8= 522; C,9=526; C,10=530; C ,11=530; 8,9= 111; 8,10=115; 8,11=114; 9,10= 117; 9,11=116; 10,11=115. IT WAS NOTED THAT THE PATIENT DID NOT HAVE ANY CHANGE IN THERAPY, NO TRAUMA AND NO FALLS. ADDITIONAL INFORMATION REPORTED INDICATED THAT THE PATIENT HAD A LESION IN THEIR LEFT TEMPORAL LOBE. THE PATIENT DENIED ANY TRAUMA OR FALLS. THERE WAS BRUISING ON THE PATIENT'S EYE LID, BUT NOT APPARENT CAUSE. THE PATIENT INDICATED THAT HE HAD HEADACHES. ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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