BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT LOCK ANCHOR

    MDR report key: 3960437 · Received July 17, 2014

    Report

    Report Number
    1627487-2014-15548
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K092371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THE PT HAS 2 ANCHORS (FROM THE SAME LOT) IMPLANTED. IT WAS REPORTED THE PT EXPERIENCED PAIN AND DISCOMFORT AT THE ANCHOR SITE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2014 AND THE ANCHORS WERE BURIED DEEPER WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420386 SWIFT LOCK ANCHOR SCS ANCHOR GZB ST. JUDE MEDICAL - NEUROMODULATION 1192 4053949

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other IMPLANT DATE:| SCS LEAD: MODEL 3186| IMPLANT DATE:| SCS IPG: MODEL 3789