BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT-LOCK ANCHOR

    MDR report key: 7214178 · Received January 23, 2018

    Report

    Report Number
    1627487-2018-00673
    Event Type
    Injury
    Date Received
    January 23, 2018
    Date of Event
    January 18, 2018
    Report Date
    March 7, 2018
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K092371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE EVENT THE DEVICE IS RETURNED TO THE MANUFACTURER, THE REPORTED EVENT CANNOT BE ANALYZED VIA LABORATORY TESTING. THE MANUFACTURER 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. THE MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME; SCS ANCHOR. PMA/510 K; K092371.

    Description of Event or Problem · 1

    DEVICE 3 OF 3, REFERENCE MFR. REPORT # 3006705815-2018-00155, 3006705815-2018-00156. IT WAS REPORTED THAT PATIENT DEVELOPED A NEW ONSET OF INFECTION AT INCISION SITE AFTER LEAD IMPLANT SURGERY ON (B)(6) 2017. PATIENT WAS TREATED WITH ANTIBIOTICS AND UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2017 WHEREIN THE DEVICE WAS REMOVED.

    Description of Event or Problem · 1

    DEVICE 3 OF 4, REFERENCE MFR. REPORT # 3006705815-2018-00155, 3006705815-2018-00156, 1627487-2018-01668. REVIEW OF THE MANUFACTURES DEVICE REGISTRATION SYSTEM INDICATED THE PATIENT WAS IMPLANTED WITH 2 ANCHORS. THE SECOND ANCHOR IS BEING ADDED TO THIS SERIES AS MFR REPORT: ( 3006705815-2018-00155, 3006705815-2018-00156, 1627487-2018-01668). THE ANCHOR WAS EXPLANTED IN THE SAME PROCEDURE AS THE ADDITIONAL DEVICES CONTAINED IN THIS SERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57351 SWIFT-LOCK ANCHOR SCS ANCHOR GZB ST. JUDE MEDICAL - NEUROMODULATION 1192 6098158

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other