BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION

    MDR report key: 3141503 · Received May 24, 2013

    Report

    Report Number
    1627487-2013-13794
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 1, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    REFERENCE MFR REPORT: 1627487-2013-13793, 1627487-2013-13795, AND 1627487-2013-13796. THE PT HAS TWO EXTENSIONS FROM THE SAME LOT NUMBER. IT WAS REPORTED, THE PT WAS IMPLANTED FOR TESTICULAR PAIN ON (B)(6) 2013. THE PT REPORTED LEG PAIN POSTOPERATIVE AND WAS HOSPITALIZED FOR SEVERAL DAYS. FOLLOW-UP IDENTIFIED THE PT HAD DEVELOPED A DVT (DEEP VEIN THROMBOSIS) IN HIS LEG AND ALSO COMPLAINED OF CHRONIC BODY PAIN. ADDITIONAL FOLLOW-UP IDENTIFIED THE PATIENT WAS RELEASED FROM THE HOSPITAL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231714 EXTENSION SCS EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3383 3434576

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R