BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE SURGICAL LEAD

    MDR report key: 1904093 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-01788
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    November 18, 2009
    Report Date
    November 18, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 SPECIFICATIONS AND NO ANOMALIES WERE FOUND. 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 INFORMATION 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 SURGICAL LEAD AND AN IPG, ON (B)(6) 2009. DURING THE INITIAL IMPLANT, THE WHITE MARKERS CAME OFF OF THE LEAD IN THE LEAD PACKAGING WHICH RESULTED IN THE TERMINAL ENDS OF THE LEAD BEING INADVERTENTLY REVERSED IN THE DEVICE HEADER. THE PHYSICIAN DISCOVERED THIS ISSUE POST-IMPLANT. THE PHYSICIAN ATTEMPTED TO REPROGRAM THE PT'S SCS SYSTEM IN ORDER TO COMPENSATE FOR THE LEAD REVERSAL; HOWEVER, HIS ATTEMPTS WERE UNSUCCESSFUL. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2010. THE LEAD WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. FOLLOW UP ON THE PT FOUND NO FURTHER ISSUES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3219 2816053

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention