BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2496832 · Received March 20, 2012

    Report

    Report Number
    3004209178-2012-01694
    Event Type
    Malfunction
    Date Received
    March 20, 2012
    Report Date
    February 23, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3387-40 LOT V004841 IMPLANTED: (B)(6) 2006 EXPLANTED: NA. LEAD MODEL 3387-40 LOT V000525 IMPLANTED: (B)(6) 2005 EXPLANTED: NA. EXTENSION MODEL 748251 (B)(4) IMPLANTED: (B)(6) 2005 EXPLANTED: NA. EXTENSION MODEL 37085-60 (B)(4) IMPLANTED: (B)(6) 2010 EXPLANTED: NA. ADAPTOR MODEL 64001 LOT N240190 IMPLANTED: (B)(6) 2010 EXPLANTED: NA. PROGRAMMER MODEL 37642 (B)(4). (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE POR WAS UNKNOWN. THE POR WAS CLEARED OUT OVER THE PHONE WITH THE PATIENT. THE SYSTEM WAS INTERROGATED ON (B)(6) 2012 AND NO ERROR CODE WAS AVAILABLE. NO CODE WAS FOUND FOR THE POR AND THE SYSTEM WAS FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    A POWER ON RESET (POR) CONDITION WAS REPORTED. THE ERROR CODE WAS NOT AVAILABLE. THERE WAS NO KNOWN EVENT THAT CAUSED THE POR. ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1