BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT-LOCK ANCHOR

    MDR report key: 6069225 · Received November 1, 2016

    Report

    Report Number
    1627487-2016-05618
    Event Type
    Injury
    Date Received
    November 1, 2016
    Report Date
    October 20, 2016
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487 -2016-05617. IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT DUE TO ANCHORS BEING SUPERFICIAL. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2016 TO REPOSITION THE ANCHORS DEEPER. IN ADDITION, THE PATIENT'S DISCOMFORT HAS BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721658 SWIFT-LOCK ANCHOR SCS ANCHORS GZB ST. JUDE MEDICAL - NEUROMODULATION 1192 4910023

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL, 3386 (2), SCS EXTENSIONS| MODEL, 3186 (2), SCS LEAD| MODEL, 3771 , SCS, IPG