BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2966723 · Received February 18, 2013

    Report

    Report Number
    6000153-2013-00020
    Event Type
    Malfunction
    Date Received
    February 18, 2013
    Report Date
    January 30, 2013
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Removal / Correction Number
    Z-0185-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS INCLUDED IN THE URGENT MEDICAL DEVICE CORRECTION LETTER, DISCUSSING LEADS BEING DAMAGED AT THE PROXIMAL CONNECTOR END OF THE LEAD WHEN THE LEAD CAP IS USED IN THE IMPLANT PROCEDURE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A LEAD DURING THE STAGE 1 IMPLANT. DURING THE STAGE 2 PORTION OF THE IMPLANT PROCEDURE, THE LEAD CAP WAS "SIDEWAYS" AND THE HCP HAD A HARD TIME GETTING THE LEAD OUT OF THE LEAD CAP. EVENTUALLY, THE HCP CUT THE CAP OFF WITH A SCISSOR-LIKE INSTRUMENT AND WAS ABLE TO REMOVE THE LEAD FROM THE CAP. IT WAS NOTED THAT THE LEAD WAS A LITTLE BIT STRETCHED OUT, BUT AN IMPEDANCE CHECK SHOWED NO PROBLEMS AND THE PATIENT WENT ON WITH IMPLANT. IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE HAD NOT SEEN THE PATIENT SINCE THE SURGERY, AND PLANNED TO SEE THEM WHEN THEY SCHEDULED THEIR APPOINTMENT AT THEIR NEUROLOGIST'S OFFICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS DOING WELL BASED ON A PROGRAMMING APPOINTMENT THAT OCCURRED THE DAY OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70169 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3389S-40 VA0199G

    Patients

    Seq Age Sex Outcome Treatment
    1