BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2963355 · Received February 15, 2013

    Report

    Report Number
    6000153-2013-00019
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 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

    ANALYSIS OF THE LEAD (LOT # VA01VU7) FOUND THAT THE DISTAL END OF THE LEAD WAS BENT. IT WAS NEW OR OUT OF BOX. THE DISTAL TIP OF THE LEAD WAS THE PART THAT WAS BENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN A LEAD PACKAGE WAS OPENED, THE TIP OF THE LEAD WAS BENT. THE PHYSICIAN OPENED AND USED A NEW LEAD. NO FURTHER INFORMATION WAS REPORTED. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68522 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3389S-40 VA01VU7

    Patients

    Seq Age Sex Outcome Treatment
    1