BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 4201951 · Received October 17, 2014

    Report

    Report Number
    1627487-2014-20330
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    July 22, 2014
    Report Date
    September 25, 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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UDI (DI): (B)(4). 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. REFERENCE MFR. REPORT #: 1627487-2014-20331. IT WAS REPORTED THE PATIENT EXPERIENCED POCKET HEATING AT THE IPG SITE WHILE CHARGING. AS A RESULT, THE SCS SYSTEM WAS EXPLANTED. ON 08/01/2012 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
    663448 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 3194817

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other IMPLANT DATE:| SCS LEAD: MODEL 3186