BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2890815 · Received December 21, 2012

    Report

    Report Number
    1627487-2012-06990
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    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
    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. REF MFR REPORT: 1627487-2012-06991. THE PT HAS AN IPG FOR OFF-LABEL USE. IT WAS REPORTED, THE PT IS EXPERIENCING HEATING WHILE RECHARGING THE IPG. A NEW CHARGER WILL BE SENT TO THE PT TO HELP RESOLVE THE ISSUE. 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
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3145882

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention SCS LEADS: MODEL 3153 (2)| IMPLANT: