BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3010517 · Received March 14, 2013

    Report

    Report Number
    1627487-2013-13292
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 1, 2012
    Report Date
    February 21, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL REPORTING NUMBER: 1627487-12192011-003-R AND 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY AND 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 2 OF 2. REFERENCE MFR REPORT # 1627487-2013-13291. THE PT REPORTED HE HAD BEEN HOSPITALIZED FOR AN UNRELATED EVENT. WHILE IN THE HOSPITAL, THE PT HAD CHARGED HIS IPG AND STATED IT BURNED HIM WHILE HE WAS CHARGING. A LOW ENERGY CHARGER WAS SENT TO THE PT. FOLLOW-UP PENDING. 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
    108418 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2793784

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention SCS LEAD: MODEL 3186| IMPLANT DATE: