BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION-1X8

    MDR report key: 1951966 · Received January 4, 2011

    Report

    Report Number
    3007566237-2011-00043
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE ELECTRICAL CONTACT WAS LOST WITH HALF THE LEAD WHEN THE DOCTOR FIXED THE PROTECTION WITH A SUTURE FILAMENT. THE CONNECTOR OF THE EXTENSION WAS FIXED WITH ONE SCREW, BUT THE CONNECTOR RING MOVED TO THE BACK WHEN A SUTURE WAS PUT IN THE MIDDLE OF THE CONNECTOR AND TIGHTENED TOO STRONGLY. THERE WERE IMPEDANCE PROBLEMS OR LEAD FAILURE FOR HALF THE ELECTRODE. THE PATIENT OUTCOME WAS NOTED AS "WE HAVE REOPERATE THE PATIENT". IT IS UNCLEAR IF THIS EVENT OCCURRED AT THE INITIAL IMPLANT OR IF AN ADD'L SURGERY WAS NEEDED. FURTHER INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION-1X8 LGW MEDTRONIC NEUROMODULATION 37081 NA

    Patients

    Seq Age Sex Outcome Treatment
    1