BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4213305 · Received October 30, 2014

    Report

    Report Number
    6000153-2014-00186
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Report Date
    October 8, 2014
    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). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE LEAD REVEALED THE FOLLOWING: THERE WERE NO ANOMALIES. IMPEDANCES WERE MEASURED ON THE RETURNED LEAD. 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

    IT WAS REPORTED THAT THERE WAS HIGH IMPEDANCE OF 21,000 PLUS ON CONTACT 0. THERE WAS A LEAD/EXTENSION ISSUE, IMPEDANCES HAD BEEN CHECKED USING ALLIGATOR CLIPS, CONTACT 0 SHOWED IMPEDANCE FROM 15,000-21,000 AND CONTACT 1 WAS NORMAL. THE DEVICE WAS NOT IMPLANTED. THE PRODUCT ISSUE WAS RESOLVED AND THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE EVENT HAD OCCURRED DURING A PROCEDURE. THE PATIENT WAS ALIVE WITH NO INJURY AND THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE PATIENT HAD NOT RECEIVED THERAPY BECAUSE IT HAD BEEN A STAGE 1 PROCEDURE. THE LEAD WAS NOT USED AND A NEW LEAD WAS WHICH WORKED FINE. THE NEW LEAD WAS PLACED THE WEEK PRIOR TO (B)(6) 2014 AND THE PATIENT WOULD NOT RECEIVE THERAPY FOR AT LEAST 4 MORE WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697540 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3389S VA0H8A7

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR