BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3182283 · Received June 21, 2013

    Report

    Report Number
    6000153-2013-00120
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    NEURO - VILLALBA
    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).

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS FOR LEAD VA07BBF REVEALED A SHORT BETWEEN THE CIRCUITS OF THE PROXIMAL END CONDUCTORS. THERE WERE LOW IMPEDANCE MEASUREMENTS BETWEEN CIRCUITS #2 AND #3. ALL OTHER ELECTRODE PAIRS WERE WITHIN NORMAL RANGE. THE #2 CONDUCTOR APPEARED TO BE CROSSED OVER THE #3 CONDUCTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOW IMPEDANCES WERE EXPERIENCED INTRA OPERATIVELY. THE IMPEDANCE MEASUREMENTS WERE: 0,1 1322 OHMS; 0,2 1315 OHMS; 0,3 1342 OHMS; 1,2 8 OHMS; 1,3 87 OHMS; 2,3 86 OHMS. IT WAS NOTED THAT A DIFFERENT NEW ELECTRODE WAS OPENED AND IMPLANTED. IT WAS LATER REPORTED THAT THE PATIENT DID NOT HAVE THE BATTERY IMPLANTED YET, JUST THE LEADS. IT WAS NOTED THE NEW LEAD USED HAD GOOD IMPEDANCES. PATIENT WAS NOT RECEIVING THERAPY YET DUE TO BATTERY NOT BEING IMPLANTED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281896 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3387S-40 VA07BBF

    Patients

    Seq Age Sex Outcome Treatment
    1 00016 YR