BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2992454 · Received March 4, 2013

    Report

    Report Number
    1627487-2013-06020
    Event Type
    Injury
    Date Received
    March 4, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 10, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY AND A FIELD CORRECTION. 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

    IT WAS REPORTED, THE PT HAD NOT CHARGED THE IPG FOR QUITE SOME TIME AND THE CHARGER NO LONGER LOCATES THE IPG. THE FIELD REPRESENTATIVE MET WITH THE PT AND VERIFIED THE IPG'S LOSS OF COMMUNICATION. SURGERY TO REPLACE THE IPG HAD BEEN SCHEDULED FOR 03/07/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91224 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3416834

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention SCS LEAD: MODEL 3228| IMPLANT DATE: