BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 4 LEAD, 60CM LENGTH

    MDR report key: 2080530 · Received April 22, 2011

    Report

    Report Number
    1627487-2011-00562
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE RECEIVED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORD FOUND A NONCONFORMANCE; HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY; THEREFORE, THE DEVICE WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. AS RECEIVED, THE RETURNED LEAD WAS CUT; THEREFORE, NO FUNCTIONAL TESTING COULD BE PERFORMED. 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 PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT'S SCS SYSTEM CONSISTED OF A NEUROSTIMULATOR RECEIVER AND A SURGICAL LEAD. IT WAS REPORTED THAT THE PT'S SCS SYSTEM WAS EXPLANTED AND REPLACED DUE TO ALLEGED OVERSTIMULATION. REFERENCE MFR REPORT # 1627487-2010-02592 FOR REPORT ON RECEIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 4 LEAD, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3240 39840

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention