BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE EXTENSION

    MDR report key: 2133585 · Received June 16, 2011

    Report

    Report Number
    1627487-2011-01664
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULTS: VISUAL ANALYSIS OF THE EXTENSION NOTED DISCOLORATION IN THE LEAD SEGMENT. BROKEN WIRES WERE OBSERVED IN THE EXTENSION HEADER. DUE TO THE BROKEN WIRES, FUNCTIONAL TESTING COULD NOT BE PERFORMED. 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

    IT WAS REPORTED THAT THE PT (B)(6) UNDERWENT SURGERY TO RECEIVE A SCS SYSTEM. DURING THE SURGERY, INTRAOPERATIVE TESTING REVEALED HIGH IMPEDANCE READINGS ON THE IMPLANTED LEAD. THE PHYSICIAN TESTED A NEW EXTENSION, AND THE IMPEDANCE ISSUE ALLEGEDLY RESOLVED. THE ORIGINAL EXTENSION WAS EXPLANTED AND REPLACED DURING THE PROCEDURE. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE EXTENSION SPINAL CORD STIMULATION EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3383 3170811

    Patients

    Seq Age Sex Outcome Treatment
    1