BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2897243 · Received January 4, 2013

    Report

    Report Number
    3004209178-2013-00163
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Report Date
    December 12, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 37642 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 37085-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 37085-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3389S-40 LOT# V813627, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3389S-40 LOT# V867003, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS NOT GETTING THERAPEUTIC BENEFIT FROM THEIR LEFT LEAD. THERE WERE "IMPEDANCE ISSUES" ON THE LEFT LEAD. THERE WERE "HIGH" IMPEDANCE RESULTS ON CIRCUITS C-1, C-2, 0-3, AND 1-3. THE IMPEDANCES WERE ABOVE 2000 OHMS ON UNIPOLAR COMBINATIONS. THE RIGHT LEAD WAS "FINE IMPEDANCE WISE". IT WAS STATED THAT THERE WAS NO SHOCKING OCCURRING ON THE LEFT LEAD AND THEY COULD NOT GET ANY EFFECT EVEN WHEN THE VOLTAGE WAS TURNED UP TO 6.8V. THERE WAS NO KNOWN REASON FOR THE HIGH IMPEDANCE VALUES. FURTHER INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4543 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1