BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT-LOCK ANCHOR

    MDR report key: 2091583 · Received April 28, 2011

    Report

    Report Number
    1627487-2011-02510
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    K092371
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: 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 3 OF 3. REFERENCE MANUFACTURER REPORT: 1627487-2011-02508 AND 1627487-2011-02509. THE PT RECEIVED AN SCS SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS (OF THE SAME LOT) AND TWO ANCHORS, ON (B)(6) 2010. IT WAS REPORTED THE PT LOST STIMULATION FROM HER SCS SYSTEM FOLLOWING A FALL IN THE SHOWER. DIAGNOSTIC TESTING OF THE LEADS FOUND HIGH IMPEDANCES. THE LEADS AND ASSOCIATED ANCHORS WERE EXPLANTED AND REPLACED. THE PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWIFT-LOCK ANCHOR SPINAL CORD STIMULATION LEAD ANCHOR LGW ST. JUDE MEDICAL - NEUROMODULATION 1192 3108444

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention IMPLANTED:| SCS IPG: MODEL 3788