BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD EXTENSION

    MDR report key: 1904292 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-02150
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    June 8, 2009
    Report Date
    June 20, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS - EXTENSION HAS SIGNIFICANT DISCOLORATION AND ALL WIRES WERE BROKEN IN HEADER. EXTENSION LEAD SEGMENT SHOWS SIGNS OF TWISTING. EXTENSION FAILED CONTINUITY TESTING WITH ALL CHANNELS MEASURING OPEN. ANS HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2010-02149.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD EXTENSION SPINAL CORD STIMULATION LEAD EXTENSION LGW ADVANCED NEUROMODULATION SYSTEMS 3383

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention