BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE SURGICAL LEAD

    MDR report key: 1910962 · Received November 23, 2010

    Report

    Report Number
    1627487-2010-03302
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 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
    OK, 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 INCOMPLETE THEREFORE IT COULD NOT BE FUNCTIONALLY TESTED. 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

    DEVICE 2 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2010-03301. THE PATIENT RECEIVED HER SCS SYSTEM CONSISTING OF A LEAD ON (B)(6) 2005 AND AN IPG ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SPORADIC STIMULATION AND THE PHYSICIAN DETERMINED THAT THE LEAD WAS FRACTURED. THE PHYSICIAN EXPLANTED AND REPLACED THE IPG AND LEAD ON (B)(6) 2010. THE DEVICES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3208 40497

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention