BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3902500 · Received June 30, 2014

    Report

    Report Number
    6000153-2014-00123
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE LEAD, LOT #VA06YVT, FOUND THE DISTAL END BENT EVEN THOUGH IT WAS NEW OUT OF THE BOX. THE DISTAL END OF THE LEAD WAS BENT AT ELECTRODE 0. THE LEAD HAD ACCEPTABLE CONTINUITY AND NO SHORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS GOING TO BE USED FOR AN IMPLANT PROCEDURE, HOWEVER UPON VISUAL EXAMINATION BY THE CLINICIAN IT WAS DECIDED THAT THE LEAD TIP WAS TOO BENT AND THE CLINICIAN DID NOT WANT TO USE IT FOR THE PROCEDURE. THE CLINICIAN WAS CONCERNED THIS COULD CAUSE INACCURACY DURING THE PLACEMENT PROCEDURE. THE REPORTER ALSO STATED THERE WAS AN EXTRA BULGE ON THE LEAD. THREE DAYS LATER IT WAS REPORTED THAT THE BULGE WAS AT THE DISTAL TIP. A DIFFERENT LEAD WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381229 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3389S-40 VA06YVT

    Patients

    Seq Age Sex Outcome Treatment
    1