BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE EXTENSION

    MDR report key: 2133625 · Received June 16, 2011

    Report

    Report Number
    1627487-2011-01667
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULTS: VISUAL ANALYSIS OF THE EXTENSIONS REVEALED DISCOLORATION IN THE HEADERS. ONE OF THE EXTENSIONS REVEALED BROKEN WIRES IN THE EXTENSION HEADER; THEREFORE, FUNCTIONAL TESTING COULD NOT BE PERFORMED ON THIS EXTENSION. THE SECOND EXTENSION PASSED ALL FUNCTIONAL 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 2 OF 2. REFERENCE MFR REPORT: 1627487-2011-01666.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE EXTENSION SPINAL CORD STIMULATION EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3386 2847825

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention