BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2881126 · Received December 14, 2012

    Report

    Report Number
    1627487-2012-12783
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 23, 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
    WY, 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 CHARGER COULD NOT LOCATE THE IPG. THE SJM REPRESENTATIVE MET WITH THE PATIENT AND CONFIRMED THAT EXTERNAL DEVICES CANNOT COMMUNICATE WITH THE IPG. FOLLOW-UP REVEALED THE PHYSICIAN REPLACED THE IPG. IT WAS REPORTED, PATIENT IS EXPERIENCING EFFECTIVE STIMULATION COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2887104

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention SCS LEAD: MODEL 3169(2)| IMPLANT DATE: