BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2801767 · Received October 17, 2012

    Report

    Report Number
    MW5027272
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    LGW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT COMPLAINED OF HEATING AND BURNING AT HIS IMPLANTABLE PULSE GENERATOR WHILE HE WAS CHARGING. HE REPORTED THAT HE FELT THE BATTERY "BURNING INSIDE HIM." HE DISCONTINUED USING THE STIMULATOR DUE TO THE DISCOMFORT. HE ALSO REPORTED THAT HIS REPORT CONTROL HAD TROUBLE COMMUNICATING WITH HIS IMPLANT. HE CALLED ST JUDE MEDICAL TO REPORT THIS PROBLEM. THE PT HAD 2 LEADS AND HIS IMPLANTABLE PULSE GENERATOR REMOVED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI EON MINI IMPLANTABLE PUSE GENERATOR LGW ST. JUDE MEDICAL NEUROMODULATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention LEAD| LEAD