BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16 SURGICAL LEAD

    MDR report key: 1910936 · Received November 23, 2010

    Report

    Report Number
    1627487-2010-03326
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. LEAD WAS RETURNED CUT AND INCOMPLETE; THEREFORE, FUNCTIONAL TESTING WAS NOT PERFORMED. INSTRUMENTATION DAMAGE WITH WIRES EXPOSED WAS OBSERVED APPROXIMATELY 0.5 CM AWAY FROM THE PADDLE. DISCOLORATION WAS NOTED IN THE LEAD SEGMENTS AND IN THE PADDLE. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM 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. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED HER SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT COULD NOT FEEL STIMULATION INTO HER LOWER BACK DESPITE SEVERAL REPROGRAMMING EFFORTS. THE PATIENT REPORTED FEELING STIMULATION NO HIGHER THAN HER BUTTOCK. THE PHYSICIAN EXPLANTED AND REPLACED THE LEAD ON (B)(6) 2010. FOLLOW UP ON THE PATIENT FOUND THAT THE PATIENT IS NOW RECEIVING STIMULATION COVERAGE ACROSS HER LOWER BACK AND NO FURTHER ISSUES HAVE BEEN REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER ON (B)(6) 2010 FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16 SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3219 2807562

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention