BEUDAMED
    FDA Adverse Event Summary report: N

    LAMITRODE S8 SURGICAL LEAD

    MDR report key: 1946288 · Received December 15, 2010

    Report

    Report Number
    1627487-2010-03099
    Date Received
    December 15, 2010
    Date of Event
    May 24, 2010
    Report Date
    May 24, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL ANALYSIS AND FUNCTIONAL TESTING WERE PERFORMED. RESULTS: AN INCOMPLETE LEAD WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE LEAD WAS CUT APPROXIMATELY 3-4 CM FROM THE PADDLE. DUE TO THE CONDITION OF THE RETURNED LEAD, NO FUNCTIONAL TESTING COULD BE PERFORMED. CONCLUSION: NO CONCLUSION CAN BE DRAWN. 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

    DEVICE 2 OF 2. REFERENCE MANUFACTURER REPORTS: 1627487-201-02708.

    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 2831909

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention