BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXXESS

    MDR report key: 3012435 · Received March 15, 2013

    Report

    Report Number
    1627487-2013-05359
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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 1 OF 2. REF MFR REPORT #: 1627487-2013-05360. IT WAS REPORTED BOTH OF THE PT'S LEADS (FOR OFF-LABEL USE) WERE EXPLANTED AND REPLACED (WITH DIFFERENT MODELS) DUE TO THE PT LOSING STIMULATION. BOTH LEADS WERE CUT WHEN THEY WERE REMOVED. THE REPLACEMENT LEADS RESOLVED THE PT'S ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110677 AXXESS SCS LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 4156 3286440

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3788