BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE EXTENSION

    MDR report key: 3141663 · Received May 24, 2013

    Report

    Report Number
    1627487-2013-12714
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    January 5, 2011
    Report Date
    April 29, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. 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

    DEVICE 3 OF 5. REFERENCE MFR REPORT #1627487-2013-12712. REFERENCE MFR REPORT #1627487-2013-12713. REFERENCE MFR REPORT #1627487-2013-12715. REFERENCE MFR REPORT #1627487-2013-12716. IT WAS REPORTED THE PT'S SCS SYSTEM WAS EXPLANTED ON (B)(6) 2011 DUE TO INFECTION. THE PT WAS GIVEN IV ANTIBIOTICS. THE INFECTION HAS CLEARED. EXPLANTED PRODUCT WAS NOT RETURNED TO SJM. NOTE: THE PT RECEIVED TWO LEADS FROM THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232348 SINGLE EXTENSION SCS EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3382 2822578

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention