BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT LOCK ANCHOR

    MDR report key: 2051544 · Received April 7, 2011

    Report

    Report Number
    1627487-2011-01369
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 11, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    GZB
    PMA / PMN Number
    K092371
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    DEVICE 2 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-01369. THE PT ((B)(6)) RECEIVED HIS SCS SYSTEM, INCLUDING TWO LEADS (FROM THE SAME LOT) AND TWO ANCHORS (FROM THE SAME LOT), ON (B)(6) 2010. THE LEADS WERE IMPLANTED OCCIPITALLY. IT WAS REPORTED THAT THE PT WAS NOT RECEIVING EFFECTIVE STIMULATION COVERAGE, AND THE PHYSICIAN DECIDED TO REVISE THE LEADS. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT BOTH LEADS WERE FRACTURED AT THE ANCHOR SITES. THE LEADS WERE EXPLANTED AND REPLACED, AND THE ANCHORS WERE EXPLANTED BUT NOT REPLACED ON (B)(6) 2011. THE FACILITY DISCARDED THE EXPLANTED DEVICES. FOLLOW UP ON THE PT FOUND THAT THE PT REPORTED EFFECTIVE STIMULATION COVERAGE. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWIFT LOCK ANCHOR SPINAL CORD STIMULATION LEAD ACCESSORY GZB ST JUDE MEDICAL - NEUROMODULATION DIV. 1192 3208620

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention