BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2585289 · Received May 23, 2012

    Report

    Report Number
    3004209178-2012-03632
    Event Type
    Malfunction
    Date Received
    May 23, 2012
    Report Date
    April 25, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LEAD MODEL 3387S-40, LOT# V951526, IMPLANTED: 2012 (B)(6), EXPLANTED: NA; LEAD MODEL 3387S-40, LOT# V951526, IMPLANTED: 2012 (B)(6), EXPLANTED: NA; EXTENSION MODEL 37085-40, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: NA; EXTENSION MODEL 37085-40, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: NA; PROGRAMMER MODEL 37642, SERIAL# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OPEN CIRCUIT WAS FOUND UPON CHECKING IMPEDANCE VALUES FOR THE FIRST TIME ON A STAGE 2 IMPLANT. ALL COMBINATIONS WITH CONTACT #11 ON THE RIGHT LEAD WERE ABOVE 40,000 OHMS. THE PATIENT'S NEUROSTIMULATOR HAD NOT BEEN TURNED ON YET, AND IT WAS NOTED THAT ALL COMPONENTS REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS 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 MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1