BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2800882 · Received October 18, 2012

    Report

    Report Number
    1627487-2012-11525
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    August 21, 2012
    Report Date
    September 26, 2012
    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 PT NO LONGER HAD STIMULATION AND WAS UNABLE TO COMMUNICATE WITH THE IPG USING THE CHARGING SYSTEM. A REPLACEMENT CHARGER WAS SENT TO THE PT. THE SJM REP MET WITH THE PT AND DETERMINED THE REPLACEMENT CHARGER HAD NOT RESOLVED THE ISSUE. IN ADDITION, THE IPG WOULD NOT COMMUNICATE WITH THE PROGRAMMER. F/U IDENTIFIED THE PHYSICIAN MAY UNDERTAKE SURGICAL INTERVENTION AT A FUTURE DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 2759785

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention SCS LEAD: MODEL 3146 (2)