BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE 8 EXTENSION

    MDR report key: 1904348 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-02366
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 22, 2008
    Report Date
    November 5, 2008
    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

    EVAL, METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS AND NO ANOMALIES WERE FOUND. EXTENSION HAS WIRES BROKEN IN HEADER AND FAILS ALL FUNCTIONAL TESTING. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. (B)(4). ANS HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT (B)(6) RECEIVED THEIR SCS SYSTEM ON (B)(6) 2007. IT WAS REPORTED THAT ALL CONTACTS WERE INVALID. THE EXTENSION WAS EXPLANTED AND REPLACED ON (B)(6) 2008. THE EXPLANTED EXTENSION WAS RETURNED TO ANS FOR EVAL. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE 8 EXTENSION SPINAL CORD STIMULATION EXTENSION LGW ADVANCED NEUROMODULATION SYSTEMS 3383 55373

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention