BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT-LOCK ANCHOR

    MDR report key: 2003732 · Received February 23, 2011

    Report

    Report Number
    1627487-2011-00245
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 27, 2011
    Manufacturer
    ST. JUDE MEDICAL -NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    K092371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 # 1627487-2011-00244. THE PT WAS IMPLANTED WITH AN SCS SYSTEM FOR KNEE PAIN ON (B)(6) 2010 CONSISTING OF AN IPG, PERCUTANEOUS LEAD AND ANCHOR. IT WAS REPORTED THAT SHE LOST STIMULATION. EFFORTS TO RECAPTURE THERAPY VIA REPROGRAMMING PROVED UNSUCCESSFUL. AN X-RAY REVEALED THAT BOTH THE PT'S LEAD AND ANCHOR HAD MIGRATED, AND THAT THE LEAD WAS BENT. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2011 TO REPLACE THE PT'S LEAD, AND EFFECTIVE STIMULATION WAS RECAPTURED AS A RESULT. THE EXPLANTED DEVICE WAS DISCARDED AND WILL NOT BE RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWIFT-LOCK ANCHOR SPINAL CORD STIMULATION ACCESSORY LGW ST. JUDE MEDICAL -NEUROMODULATION DIV. 1192 3053825

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention