BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44 SURGICAL LEAD

    MDR report key: 2042069 · Received March 31, 2011

    Report

    Report Number
    1627487-2011-02391
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: AN INCOMPLETE LEAD WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. VISUAL INSPECTION NOTED CUTS IN THE OUTER TUBING AND PADDLE. IN ADDITION, INSTRUMENT MARKS ON THE OUTER TUBING WERE OBSERVED. DUE TO THE CONDITION OF THE RETURNED LEAD, NO FUNCTIONAL TESTING COULD BE PERFORMED. THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 HIS SCS SYSTEM, INCLUDING A SURGICAL LEAD, ON (B)(6) 2010. IT WAS REPORTED THE LEAD WAS EXPLANTED AND REPLACED DUE TO INEFFECTIVE STIMULATION. ALTHOUGH THE EXPLANTED LEAD WAS PRODUCING STIMULATION IN THE DESIRED AREA, THE STIMULATION WAS UNEVEN THROUGHOUT THE COVERAGE AREA. FOLLOW UP ON THE PT FOUND THAT STIMULATION WAS RESTORED WITH THE REPLACEMENT LEAD.

    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 3244 2825338

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention