BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2042060 · Received March 31, 2011

    Report

    Report Number
    1627487-2011-02388
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: LEAD A WAS RETURNED WITH OUTER TUBING KINKS, DISCOLORATION AND BREACHES TO THE OUTER TUBING. SIMILARLY, LEAD B ALSO HAD OUTER TUBING KINKS, BREACHES TO THE OUTER TUBING AND COMPRESSION DAMAGE. FUNCTIONAL TESTING OF BOTH LEADS FOUND ONE INVALID CONTACT ON LEAD B ONLY. LEAD A EXHIBITED NO FUNCTIONAL ANOMALIES. THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS AND NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. 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 PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED HER SCS SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS (OF THE SAME LOT) ON (B)(6) 2011. IT WAS REPORTED THE PT LOST STIMULATION FROM HER SCS SYSTEM AFTER A RECENT FALL. DIAGNOSTIC TESTING OF THE LEADS FOUND INVALID CONTACTS ON BOTH. THE LEADS WERE EXPLANTED AND REPLACED. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    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 3101876

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention