BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 4151799 · Received October 6, 2014

    Report

    Report Number
    1627487-2014-12659
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER WAS INCLUDED IN A FIELD CORRECTION. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REF MFR REPORT #1627487-2014-12660. IT WAS REPORTED THE PT EXPERIENCES HEATING AT THE IPG POCKET SITE WHEN CHARGING. THE PT ALSO REPORTED DARK MARKS OVER THE IPG. THE PHYSICIAN DOES NOT BELIEVE THE MARKS ARE RELATED TO THE SCS SYSTEM. A REPLACEMENT CHARGER WAS SENT TO THE PT. ON (B)(4)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
    623368 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 97739

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other IMPLANT DATE:| SCS LEAD, MODEL 3214,