BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1910896 · Received November 23, 2010

    Report

    Report Number
    1627487-2010-03633
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    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. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. EVAL SUMMARY: AS RECEIVED, THE LEADS WERE INCOMPLETE; BOTH MISSING THE TERMINAL END. BOTH LEADS SHOWED SIGNS OF COMPRESSION DAMAGE THROUGHOUT THE LEAD BODY. LEAD A ALSO HAD SOME DISCOLORATION. LEAD B WAS SEVERELY KINKED WITH ALL WIRES BROKEN APPROXIMATELY 43.5CM FROM THE STIM END. UNFORTUNATELY, NO FUNCTIONAL TESTING WAS PERFORMED AS THE LEADS WERE INCOMPLETE. 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

    DEVICE 1 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2010-03634. THE PT RECEIVED AN SCS SYSTEM INCLUDING TWO PERCUTANEOUS LEADS (OF THE SAME LOT) AND AN IPG. IT WAS REPORTED THE LEADS WERE EXPLANTED AND REPLACED DUE TO HIGH IMPEDANCES, A LOSS OF STIMULATION AND LEAD MIGRATION. ACCORDING TO THE PT'S MEDICAL HISTORY, SHE HAS SUSTAINED A NUMBER OF FALLS SINCE THE ORIGINAL IMPLANT. DURING THE LEAD REVISION PROCEDURE ON (B)(6) 2010, THE PHYSICIAN SURGICALLY REPOSITIONED THE IPG HIGHER IN THE IMPLANT POCKET. THE ORIGINAL LOCATION RESULTED IN THE PT SITTING ON HER IPG. THE EXPLANTED LEADS WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. FOLLOW UP ON THE PT FOUND, NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 2787306

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention