BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6459871 · Received April 5, 2017

    Report

    Report Number
    3004209178-2017-07036
    Event Type
    Malfunction
    Date Received
    April 5, 2017
    Date of Event
    March 9, 2017
    Report Date
    April 5, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    UDI-DI
    00613994934604
    PMA / PMN Number
    H020007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3387S-40, LOT# VA074JR, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A MANUFACTURER REPRESENTATIVE (REP) REPORTED HIGH IMPEDANCES SEEN DURING AN ADJUSTMENT TO PROGRAMMING AT A NORMAL FOLLOW UP VISIT WITH THE PATIENT ON DATE NOTIFIED. THE PATIENT'S ACTIVE PARAMETERS ARE C+ 9- 10-, AND AN IMPEDANCE CHECK SHOWED HIGH IMPEDANCES >2000 UNIPOLAR, >4000 BIPOLAR ON CONTACT 11. SPECIFICALLY, C/11 = 11225 OHMS, 13 = 13 164, 9/11 = 11775, 10/11 = 10368. THE OUT OF RANGE ELECTRODE IS NOT BEING USED IN PROGRAMMING OR CAUSING THERAPY ISSUES. THERE WERE NO HISTORICAL IMPEDANCE VALUES WITH IT NOTED THAT THE PATIENT HAS BEEN GETTING GOOD THERAPY. THE IMPEDANCE ISSUE WILL CONTINUE TO BE MONITORED. NO FURTHER COMPLICATIONS ARE ANTICIPATED. THE PATIENT'S INDICATION FOR IMPLANT IS DYSTONIA AND MOVEMENT DISORDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241736 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601 00613994934604

    Patients

    Seq Age Sex Outcome Treatment
    1