BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT-LOCK ANCHOR

    MDR report key: 1980331 · Received February 2, 2011

    Report

    Report Number
    1627487-2011-00142
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    K092371
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    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. REFERENCE MFR REPORT # 1627487-2011-00141. THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2010 INCLUDING TWO PERCUTANEOUS LEADS AND TWO ANCHORS. IT WAS REPORTED THAT SHE UNDERWENT A SURGICAL REVISION ON (B)(6) 2011 DUE TO LEAD MIGRATION. DURING THE COURSE OF THE PROCEDURE, THE TWO ANCHORS ALLEGEDLY BROKE. THE PHYSICIAN SUCCESSFULLY REPOSITIONED THE LEADS AND USED TWO NEW ANCHORS TO SECURE THE DEVICE. THE PT IS SAID TO BE RECEIVING EFFECTIVE STIMULATION AND THERAPY COVERAGE SINCE THE PROCEDURE. THE ANCHORS WERE RETURNED TO THE MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWIFT-LOCK ANCHOR SPINAL CORD STIMULATION ACCESSORY LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 1192 2857543

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention