BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCHOR

    MDR report key: 3110883 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-12632
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    K092371
    Adverse Event
    Yes
    Product Problem
    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 PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REF MFR REPORT #1627487-2013-12631. IT WAS REPORTED THE PT HAS SWELLING AT THE LEAD INCISION SITE. X-RAYS REVEALED ONE OF THE LEADS HAS MIGRATED AND THE ANCHOR WAS DISPLACED. THE PT HAS ADEQUATE STIMULATION FROM THE OTHER LEAD. THE PHYSICIAN WILL MONITOR THE SWELLING. NOTE: THE PT HAS TWO LEADS FROM THE SAME LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204861 ANCHOR SCS ANCHOR LGW ST JUDE MEDICAL - NEUROMODULATION 1192 3891405

    Patients

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