BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2842917 · Received November 21, 2012

    Report

    Report Number
    6000153-2012-00230
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    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

    ANALYSIS OF THE LEAD (PRODUCT# 3387S-40, LOT# VA03Y4Z) FOUND NO ANOMALY. IMPEDANCES WERE MEASURED AND THEY WERE FOUND TO BE GOOD ON EVERY ELECTRODE PAIR.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO IMPLANT CONTACTS 1 AND 3 WERE REVEALED TO HAVE A SHORT CIRCUIT WITH IMPEDANCES OF 30 OHMS. ALL OTHER CONTACT PAIRS AND MONOPOLAR IMPEDANCES WERE NORMAL. THE LEAD WAS NEVER IMPLANTED AND THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3387S-40 VA03Y4Z

    Patients

    Seq Age Sex Outcome Treatment
    1