BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1910905 · Received November 23, 2010

    Report

    Report Number
    1627487-2010-03610
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: THE ALLEGED LEAD MIGRATION CANNOT BE CONFIRMED BY THE MFR THROUGH LABORATORY TESTING. 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 MFR REPORT: 1627487-2010-03611. THE PT RECEIVED HIS SCS SYSTEM, INCLUDING A PERCUTANEOUS LEAD AND ANCHOR, ON (B)(6) 2010. IT WAS REPORTED THE PT LOST STIMULATION AFTER A RECENT FALL. AN X-RAY REVEALED THE ANCHOR HAD FRACTURED AND THE LEAD MIGRATED, PULLING BACK THROUGH THE ANCHOR. THE LEAD AND ANCHOR WERE EXPLANTED AND NOT REPLACED DUE TO DIFFICULTIES WITH THE PT'S ANATOMY. THE PT WILL BE REIMPLANTED AT A LATER DATE. THE EXPLANTED ANCHOR AND LEAD WERE RETURNED TO THE MFR 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 3189 2854113

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention