BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2903123 · Received January 2, 2013

    Report

    Report Number
    1627487-2013-03013
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 18, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    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. REF MFR REPORT: 1627487-2013-03014. THE PT REPORTED EXPERIENCING UNCOMFORTABLE HEATING FROM HER CHARGING SYSTEM WHILE CHARGING HER SCS SYSTEM WHICH SUBSEQUENTLY CAUSES HER SCS IPG POCKET SITE TO BEING HEATING. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PT. ON 08/01/2012 ST JUDE MEDICAL, NEUROMODULATION DIV., SENT FIELD ACTION LETTERS TO PTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS ARE EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1326 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3152659

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3228