BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC

    MDR report key: 2940663 · Received January 29, 2013

    Report

    Report Number
    1627487-2013-12128
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 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 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

    IT WAS REPORTED, THE IPG SHOWED A 'LOW IPG' MESSAGE AND STIMULATION WOULD NOT START DURING A LEAD REPLACEMENT SURGERY. ALSO, THE PT TURNED OFF THE STIMULATION TWO MONTHS AGO. THE PHYSICIAN DECIDED TO REPLACE THE IPG AS A PRECAUTION. POST-OPERATIVE PROGRAMMING PROVIDED EFFECTIVE STIMULATION COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39497 EONC SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3688 3718850

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention IMPLANT:| SCS LEAD: MODEL 3189