BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT LOCK ANCHOR

    MDR report key: 3193642 · Received June 25, 2013

    Report

    Report Number
    1627487-2013-15855
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K092371
    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 3 OR 3. REFERENCE MFR REPORT: 1627487-2013-15853, REFERENCE MFR REPORT: 1627487-2013-15854. THE PT HAD 2 LEADS (FROM THE SAME LOT) AND 2 ANCHORS (FROM THE SAME LOT) AS PART OF HER SCS SYSTEM. IT WAS REPORTED THE PT WAS UNABLE TO USE HER SCS SYSTEM DUE TO PAIN IN HER BACK OR RIBS WHEN STIMULATION WAS ON. ADDITIONALLY, THE PT EXPERIENCED PAIN AT THE INCISION SITE WHERE THE ANCHOR IS LOCATED. THE PT IS THIN AND STATED THAT SHE WAS ABLE TO FEEL THE ANCHOR. THE SJM REP MET WITH THE PT AND IMPEDANCES WERE NORMAL. THE PT'S SCS SYS WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287788 SWIFT LOCK ANCHOR SCS ANCHOR GZB ST. JUDE MEDICAL - NEUROMODULATION 1192 3754705

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other