BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2251074 · Received September 8, 2011

    Report

    Report Number
    6000153-2011-07583
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    September 2, 2011
    Report Date
    November 16, 2011
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE LEAD REVEALED THE DISTAL END WAS BENT. CONTINUITY WAS ACCEPTABLE AND THERE WERE NO SHORTS BETWEEN CIRCUITS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE TIP OF THE LEAD WAS BENT WHEN IT WAS TAKEN OUT OF THE BOX. 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 3389 V719692

    Patients

    Seq Age Sex Outcome Treatment
    1