BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE 44 SURGICAL LEAD

    MDR report key: 1919506 · Received November 23, 2010

    Report

    Report Number
    1627487-2010-02865
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 6, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD: VISUAL AND FUNCTIONAL TESTING WERE PERFORMED ON THE LEADS. IN ADDITION, THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. THE LEADS WERE VISUALLY INSPECTED AND FOUND TO HAVE ELECTROCAUTERY INSTRUMENTATION DAMAGE, AS WELL AS, BROKEN AND DAMAGED WIRES. THE LEADS FAILED CONTINUITY TESTING WITH SEVERAL CHANNELS MEASURED AS OPEN. CONCLUSION: THE REPORTED COMPLAINT WAS CONFIRMED. AS RECEIVED, THE LEADS WERE DAMAGED AND ALL THE WIRES WERE BROKEN IN THE PADDLE. TESTING REVEALED SEVERAL OPEN CHANNELS. THIS MDR IS BEING SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO AN FDA INSPECTION. WE ARE SUBMITTING THIS MDR AS THE RESULT OF A RE-EVALUATION OF OUR MDR REVIEW PROCESS. SJM 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. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED HER SCS SYSTEM, INCLUDING TWO SURGICAL LEADS (OF THE SAME LOT), ON (B)(6) 2009. IT WAS REPORTED THE LEADS WERE EXPLANTED AND REPLACED DUE TO A LOSS OF STIMULATION AND UNACCEPTABLE IMPEDANCE. THE EXPLANTED LEADS WERE RETURNED TO THE MFR FOR ANALYSIS. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44 SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3263 2787284

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention