BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3012750 · Received March 20, 2013

    Report

    Report Number
    6000153-2013-00041
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    January 30, 2013
    Report Date
    March 19, 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

    (B)(4) - FINAL DEVICE ANALYSIS OF THE LEAD (LOT # V671650) REVEALED THE FOLLOWING: THE DISTAL TIP OF THE LEAD WAS BENT AT THE #1 ELECTRODE SLEEVE (NEW OUT OF BOX).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD WAS REMOVED FROM THE BOX AND VISUAL INSPECTION FROM OUTSIDE THE POUCH CONFIRMED THAT THE LEAD TIP WAS BENT. THE LEAD WAS NOT USED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115018 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 338940 V671650

    Patients

    Seq Age Sex Outcome Treatment
    1