BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4172691 · Received October 10, 2014

    Report

    Report Number
    1627487-2014-26837
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 1, 2014
    Report Date
    September 18, 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
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION. SJM HAS LIMITED INFO 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: 1627487-2014-26838. THE PT REPORTS SHE EXPERIENCED UNCOMFORTABLE POCKET HEATING WHILE RECHARGING. SHE REPORTS THE HEATING HAS BECOME UNCOMFORTABLE TO THE POINT SHE HAD TO STOP CHARGING. A REPLACEMENT MODEL 3722 CHARGING SYSTEM WAS SENT TO THE PT AND THE ISSUE IS RESOLVED. 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 THE OTHER NON-REPORTED EVENTS WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643313 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3711871

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other IMPLANT DATE:| SCS ANCHOR: MODEL 1192| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| SCS LEAD: MODEL 3186| IMPLANT DATE:| SCS LEAD: MODEL 3286