BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXXESS QUAD LEAD 3/4MM, 30CM

    MDR report key: 2103734 · Received May 24, 2011

    Report

    Report Number
    1627487-2011-00711
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 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 INFORMATION 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 3 OF 5. REFERENCE MFR REPORT #S: 1627487-2011-00709, 1627487-2011-00710, 1627487-2011-00712, AND 1627487-2011-00713. THE PT REC'D AN SCS SYSTEM INCLUDING AN IPG, THREE PERCUTANEOUS LEADS AND A LEAD EXTENSION. IT WAS REPORTED THAT THE PT'S SCS SYSTEM WAS EXPLANTED DUE TO HIGH POWER REQUIREMENTS AND PREVIOUS ALLEGATIONS OF INEFFECTIVE STIMULATION FROM THE SYSTEM. THE PT HAS ELECTED NOT TO BE REIMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXXESS QUAD LEAD 3/4MM, 30CM SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL- NEUROMODULATION 4143 R55697

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention