BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5516757 · Received March 22, 2016

    Report

    Report Number
    2649622-2016-02810
    Event Type
    Malfunction
    Date Received
    March 22, 2016
    Date of Event
    March 17, 2016
    Report Date
    March 23, 2016
    Manufacturer
    MPRI
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED LEAD WAS ATTACHED TO A KNOWN GOOD SCREENING CABLE. THE DISTAL END OF THE LEAD WAS PLACED INTO A 0.9% SALINE SOLUTION. USING AN 8840 PROGRAMMER TO COMMUNICATE TO THE ENS THAT WAS CONNECTED TO THE SCREENING CABLE, IMPEDANCES WERE MEASURED. NORMAL IMPEDANCES WERE MEASURED ON ALL CIRCUITS AND ELECTRODE PAIR COMBINATIONS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT A LEAD HAD HIGH IMPEDANCES AT 1.5V WITH THE TWISTLOCK CABLE DURING A STAGE I PROCEDURE; THE ISSUE WAS OUT OF THE BOX. IMPEDANCES WERE AS FOLLOWS: 0<(>&<)>1=9711 OHMS, 0<(>&<)>2=3384 OHMS, 0<(>&<)>3=2659 OHMS, 1<(>&<)>2=10460 OHMS, 1<(>&<)>3=9559 OHMS, 2 <(>&<)>3=2975 OHMS. A SECOND IMPEDANCE MEASUREMENT WAS PERFORMED AND ALSO RESULTED IN HIGH IMPEDANCES IN THE 6,000 OHMS RANGE. THE LEAD WAS REPLACED AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173282 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MPRI 3387S-40 VA1026D

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR