BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFTLOCK ANCHOR

    MDR report key: 1880313 · Received October 20, 2010

    Report

    Report Number
    1627487-2010-02887
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    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

    EVAL, METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS 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. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 3 OF 3. PLEASE SEE MFG REPORT NUMBERS 1627487-2010-02833AND 1627487-2010-02886 FOR DEVICES 1 AND 2. ON (B)(6) 2010, THE PT WAS IMPLANTED WITH A SCS SYSTEM. ON (B)(6) 2010, THE SYSTEM WAS EXPLANTED DUE TO INFECTION. NO OTHER INFO IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWIFTLOCK ANCHOR IMPLANTED SCS FOR PAIN RELIEF, ANCHOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 1192 3078405

    Patients

    Seq Age Sex Outcome Treatment
    1 Other