BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEEP BRAIN STIMULATION LEAD KIT

    MDR report key: 1884847 · Received October 15, 2010

    Report

    Report Number
    6000153-2010-08000
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    April 21, 2010
    Report Date
    September 20, 2010
    Manufacturer
    MPROC, VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL DEVICE ANALYSIS REVEALED RELIABILITY NON-CONFORMANCE ON LEAD (B)(4). CONTINUITY WAS ACCEPTABLE, NO SHORTS. THERE WAS A SLIGHT BEND AT THE DISTAL TIP OF THE LEAD. THE LEAD WAS NEW OUT OF THE BOX. THE DISTAL TIP OF THE LEAD HAD A BEND OF .007 IN. THE OUTER INSULATION WAS INTACT. THE PROXIMAL END WAS INTACT AND DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED, LEAD WAS OBSERVED TO HAVE A SLIGHT CURVE OR DEVIATION AT THE DISTAL TIP, PRE-IMPLANT. THE PHYSICIAN ASKED FOR LEAD TO BE OPENED AND HANDED OFF INTO STERILE FIELD. THE LEAD TRAY WAS OPENED AND PLACED ON BACK TABLE. EACH TASK WAS ACCOMPLISHED AND UNEVENTFUL. PHYSICIAN PICKED UP LEAD AND REMOVED FROM STRAW FOR INSPECTION. UPON INSPECTION LEAD WAS OBSERVED TO HAVE A SLIGHT CURVE OR DEVIATION AT THE DISTAL TIP. THE CURVE WAS SIGNIFICANT ENOUGH TO CAUSE CONCERN RELATIVE TO PLACEMENT PRECISION. PHYSICIAN ASKED FOR A NEW LEAD TO BE PASSED OFF. THE LEAD NEVER MADE CONTACT WITH PATIENT. THE DEVICE WAS NOT IMPLANTED AND NOT USED IN THE PATIENT. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND WILL BE PROVIDED WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD KIT MHY MPROC, VILLALBA 3387S

    Patients

    Seq Age Sex Outcome Treatment
    1