BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2820158 · Received November 2, 2012

    Report

    Report Number
    1627487-2012-02601
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    September 25, 2012
    Report Date
    October 8, 2012
    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

    CORRECTION: 1627487-05242011-002-R, 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION AND FIELD ADVISORIES. SJM HAS LIMITED INFORMATION 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: 1627487-2012-02602. IT WAS REPORTED, THE PT FELT UNCOMFORTABLE HEATING AT HIS IPG POCKET SITE WHILE CHARGING. THE PT STATED HE HAS LOST ABOUT 30 POUNDS AND HIS IPG IS MORE SUPERFICIAL. IT WAS REPORTED, THE PT HAS A FREQUENT RECHARGE BURDEN DUE TO HIS SYSTEM'S HIGH POWER REQUIREMENTS AND HE TYPICALLY CHARGES FOR 3-4 HOURS PER DAY. FOLLOW-UP IDENTIFIED THE PT'S STIMULATION TURNED OFF ON ITS OWN. THE PT REPORTED THIS ISSUE OCCURS ABOUT ONE WEEK PER MONTH. THE PT ALLEGEDLY WAS ABLE TO TURN THE STIMULATION BACK ON USING HIS PROGRAMMER. IT WAS REPORTED SURGICAL INTERVENTION WILL BE UNDERTAKEN TO ADDRESS THE ISSUES. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3161513

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention SCS LEAD: MODEL 3228| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| IMPLANT DATE: