BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3012143 · Received March 13, 2013

    Report

    Report Number
    1627487-2013-06052
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD CORRECTION AND FIELD ADVISORY. 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 4. REFERENCE MFR REPORT: 1627487-2013-06053, 06054, 06055. IT WAS REPORTED THE PT EXPERIENCES HEATING WHILE RECHARGING. THE PT HAS TWO SYSTEMS, BUT HE STATED HE ONLY USES ONE CHARGER TO CHARGE BOTH IPGS AND HE EXPERIENCES HEATING WHEN CHARGING BOTH IPGS. ALSO, THE PT REQUESTED ONLY ONE REPLACEMENT CHARGER BE SENT AS HE DOES NOT WANT TO HAVE TWO CHARGERS. A LOW ENERGY CHARGER WAS SENT TO ADDRESS THIS ISSUE. F/U INDICATES THE NEW CHARGER IS WORKING FINE AND THE PT IS NO LONGER EXPERIENCING ANY HEATING WHILE CHARGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106702 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3395367

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention SCS LEAD: MODEL 3228| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3286