BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT LOCK ANCHOR

    MDR report key: 4163274 · Received October 8, 2014

    Report

    Report Number
    1627487-2014-15734
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P092371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM 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. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REF MFR REPORT: 1627487-2014-15733. THE PT HAS 2 ANCHORS (FROM THE SAME LOT) IMPLANTED AS PART OF HIS SCS SYSTEM. IT WAS REPORTED THE PT IS EXPERIENCING PAIN AT THE IPG AND ANCHOR SITE. THE PT HAS NOT USED HIS SCS SYSTEM FOR AN EXTENDED PERIOD OF TIME (REF MFR REPORT: 1627487-2013-17442). THE PT DESIRES TO HAVE THE SYSTEM EXPLANTED. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633864 SWIFT LOCK ANCHOR SCS ANCHOR GZB ST JUDE MEDICAL - NEUROMODULATION 1192 3944096

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other IMPLANT DATE:| SCS LEAD, MODEL: 3186 (2)