BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2890793 · Received December 21, 2012

    Report

    Report Number
    1627487-2012-15103
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    July 1, 2009
    Report Date
    December 4, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL NUMBER: 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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

    IT WAS REPORTED THE PT HAD NOT CHARGED HER IPG FOR AN EXTENDED PERIOD OF TIME DUE TO UNDERGOING MULTIPLE SURGERIES FOR OTHER ISSUES. AN SJM REP MET WITH THE PT AND CONFIRMED THE IPG WILL NO LONGER COMMUNICATE WITH EXTERNAL DEVICES. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2798819

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention SCS LEAD: MODEL 3219| IMPLANT DATE: