BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2921988 · Received January 4, 2013

    Report

    Report Number
    1627487-2013-02021
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 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

    CORRECTION: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT'S IPG WAS UNABLE TO COMMUNICATE WITH HIS CHARGER AND PROGRAMMER. A REPLACEMENT CHARGER WAS UNABLE TO RESOLVE THE ISSUE. THE PATIENT REPORTED, HE WENT OUT OF THE COUNTRY AND FORGOT HIS CHARGER; THEREFORE, HE WAS UNABLE TO CHARGE HIS IPG FOR OVER A MONTH. THE PHYSICIAN EXPLANTED AND REPLACED THE IPG. THE PATIENT REPORTED EFFECTIVE STIMULATION POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5405 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2893988

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention SCS ANCHOR, MODEL 1192| IMPLANT DATE:| SCS LEAD, MODEL 3189| IMPLANT DATE: