BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE EXTENSION

    MDR report key: 4252652 · Received November 5, 2014

    Report

    Report Number
    1627487-2014-12733
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 ST. SJM HAS LIMITED INFORMATION 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 3. REFERENCE MFR REPORT: 1627487-2014-12431, 12433. NOTE: THE PT RECEIVED 2 EXTENSIONS FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PT HAS AN INFECTION, INITIAL SITE OF INFECTION IS UNK. SURGICAL INTERVENTION WAS PERFORMED ON (B)(6) 2014 WHERE THE IPG AND LEAD WERE EXPLANTED AND REPLACED. IT IS UNK IF THE EXTENSIONS WERE EXPLANTED (DEVICE 3.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710181 SINGLE EXTENSION SCS SINGLE EXTENSION GZB ST. JUDE MEDICAL - NEUROMODULATION 3383 2852537

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other