BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXXESS PERCUTANEOUS LEAD

    MDR report key: 2133654 · Received June 16, 2011

    Report

    Report Number
    1627487-2011-01674
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    December 1, 2010
    Report Date
    May 19, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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

    THE PT RECEIVED HIS SCS SYSTEM, INCLUDING A PERCUTANEOUS LEAD, ON (B)(6) 2010. IT WAS REPORTED THAT THE PT'S STIMULATION CHANGED IN (B)(6) 2010 AFTER A FALL. REPROGRAMMING WAS UNSUCCESSFUL IN PROVIDING EFFECTIVE STIMULATION COVERAGE. THE PT REPORTED UNINTENDED AND INEFFECTIVE STIMULATION DURING THE SESSION. THE PHYSICIAN PERFORMED AN X-RAY OF THE PT'S SCS SYSTEM. ATTEMPTS TO OBTAIN ADDITIONAL INFO REGARDING THE PT'S CONDITION AND/OR DEVICE STATUS WERE UNSUCCESSFUL. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXXESS PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 4143 3137480

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention