BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE 44 PADDLE LEAD

    MDR report key: 1790904 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01575
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    February 27, 2008
    Report Date
    February 27, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    K992946
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, 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. LEAD WIRES ARE BROKEN AND THE LEAD IS KINKED ABOUT 7 CM FROM THE PADDLE STRAIN RELIEF. LEAD FAILS CONTINUITY 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 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

    THE PATIENT RECEIVED HIS SCS SYSTEM CONSISTING OF A PADDLE LEAD AND NEUROSTIMULATOR RECEIVER ON (B)(6) 2007. IT WAS REPORTED THAT THE PATIENT LOST STIMULATION ON (B)(6) 2008. AN X-RAY SHOWED A BREAK IN THE LEAD. THE ENTIRE SCS SYSTEM WAS REPLACED ON (B)(6) 2008. THE PHYSICIAN ELECTIVELY DECIDED TO REPLACE THE RECEIVER WITH AN IPG WHILE REPLACING THE LEAD. BOTH THE LEAD AND THE RECEIVER WERE RETURNED TO ANS FOR ANALYSIS. FOLLOW UP ON THE PATIENT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44 PADDLE LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3244 64744

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention