BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3946376 · Received July 11, 2014

    Report

    Report Number
    1627487-2014-25506
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    March 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    ST JUDE MED - 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 #: 1627487-2014-25507. IT WAS REPORTED THE PATIENT EXPERIENCED POCKET HEATING WHILE CHARGING. SUBSEQUENTLY, THE PATIENT WAS SENT A REPLACEMENT CHARGING SYSTEM. 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
    406901 EON SCS IPG GZB ST JUDE MED - NEUROMODULATION 3716 45896A

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other IMPLANT DATE:| SCS LEAD, MODEL: 3245