BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 4202558 · Received October 22, 2014

    Report

    Report Number
    1627487-2014-01666
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    June 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION. SJM HAS LIMITED INFORMATION 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# 1627487-2014-01667. IT WAS REPORTED THE PT EXPERIENCED UNCOMFORTABLE POCKET HEATING WHILE RECHARGING FOR THE PAST SEVERAL MONTHS. A REPLACEMENT CHARGING SYSTEM WAS SENT. ON 08/01/2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, 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 WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673903 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 115832

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other IMPLANT DATE:| SCS LEAD: MODEL 3186(2)