BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3946387 · Received July 11, 2014

    Report

    Report Number
    1627487-2014-20031
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    January 1, 2013
    Report Date
    June 16, 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
    TX, 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 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# 1627487-2014-20032. IT WAS REPORTED THE PATIENT EXPERIENCED INCREASED RECHARGE BURDEN WHICH RESULTED IN HEATING AT HER SCS IPG POCKET SITE WHILE CHARGING. IT WAS ALSO REPORTED THE SCS IPG BECAME INOPERABLE DUE TO THE INABILITY TO ESTABLISH COMMUNICATION WITH HER EXTERNAL DEVICES. THE SJM REPRESENTATIVE CONFIRMED THE ISSUE. AS A RESULT, THE IPG WAS EXPLANTED AND REPLACED WHICH RESOLVED THE ISSUE. ON (B)(6) 2012 ST JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PATIENTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PATIENTS. 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
    406925 EON SCS IPG GZB ST JUDE MEDICAL - NEUROMODULATION 3716 119589

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other IMPLANT DATE:| SCS LEAD, MODEL 3186(2)| IMPLANT DATE:| SCS EXTENSION, MODEL 3383(2)