BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8 SURGICAL LEAD

    MDR report key: 1911751 · Received November 19, 2010

    Report

    Report Number
    1627487-2010-03604
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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. EVAL SUMMARY: AS RECEIVED, THE LEAD WAS MISSING THE CHANNEL 2 ELECTRODE. THE LEAD HAD OUTER TUBE COMPRESSION DAMAGE AND ELECTROCAUTERY INSTRUMENTATION DAMAGE. TISSUE WAS OBSERVED AT THE TERMINAL END ELECTRODES AND THERE WAS DISCOLORATION IN THE LEAD PADDLE. IT IS UNK WHAT CAUSE THE ELECTRODE TO COME OFF FROM THE PADDLE. 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 A SURGICAL LEAD, ON (B)(6) 2010. IT WAS REPORTED THE LEAD WAS EXPLANTED AND REPLACED DUE TO A LOSS OF STIMULATION. ONCE EXPLANTED, THE PHYSICIAN NOTED THE LEAD WAS MISSING AN ELECTRODE. THE ELECTRODE WAS RECOVERED FROM THE EPIDURAL SPACE. THE EXPLANTED LEAD WAS 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 S8 SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3286 2852536

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention