BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1895434 · Received November 4, 2010

    Report

    Report Number
    1627487-2010-03171
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORD FOUND A NONCONFORMANCE RELATED TO THE PRODUCT. THE TOTAL LOT SIZE WAS 120. THREE UNITS OF THE LOT WERE FOUND TO HAVE FOREIGN MATERIAL IN THE TRAY. ONE UNIT WAS FOUND TO HAVE A BROKEN TRAY. THE FOUR AFFECTED UNITS WERE REMOVED FROM THE PRODUCTION LOT NUMBER AND THE REMAINING BALANCE WAS APPROVED FOR USE. 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 HAD TWO PERCUTANEOUS LEADS PLACE ON (B)(6) 2010. DURING THE IMPLANT PROCEDURE, SHE BEGAN TO BLEED PROFUSELY. THE CASE WAS ABORTED, AND THE LEADS WERE REMOVED AND DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3186 3170781

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention