BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3193666 · Received June 25, 2013

    Report

    Report Number
    1627487-2013-06524
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-0726012-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION. 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-06525. IT WAS REPORTED, THE PT HAS BEEN EXPERIENCING UNCOMFORTABLE HEATING AT THE IPG WHILE CHARGING AS WELL AS NORMAL USE. THE PT HAS THE SYSTEM TURNED OFF. AN SJM REP MET WITH THE PT AND THE PT REPORTED SHE RECEIVED A REPLACEMENT CHARGER AND SHE NO LONGER IS EXPERIENCING ANY HEATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287845 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3511319

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other SCS LEAD: MODEL 3228| IMPLANT: