BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE 44 LEAD, 60CM LENGTH

    MDR report key: 1904360 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-02336
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    May 29, 2008
    Report Date
    June 23, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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. LEAD SEVERELY KINKED WITH ALL WIRES BROKEN. 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 RECEIVED HIS SCS SYSTEM INCLUDING A PADDLE LEAD ON (B)(6) 2006. IT WAS REPORTED THAT AFTER A FALL, THE PT EXPERIENCED A SIGNIFICANT CHANGE IN IMPEDANCE LEVELS AND WAS NO LONGER RECEIVING STIMULATION. THE SYSTEM WAS REPLACED ON (B)(6) 2008. THE EXPLANTED LEAD WAS RETURNED FOR EVAL. FOLLOW UP ON THE PT FOUND THAT NO FURTHER ISSUES HAVE BEEN REPORTED. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44 LEAD, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3244 37948

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention