BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3161735 · Received June 5, 2013

    Report

    Report Number
    1627487-2013-15763
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 14, 2012
    Report Date
    May 14, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL NUMBER: 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. SJM HAS LIMITED INFO 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

    THE PT REPORTED HE HAD NOT USED OR CHARGED HIS IPG IN APPROX 1 YEAR. SUBSEQUENTLY, HE IS UNABLE TO COMMUNICATE WITH OR CHARGE HIS IPG. THE PT DOES NOT WISH TO PURSUE ANY INTERVENTION REGARDING HIS SCS SYSTEM AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248788 EON MINI SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3788 3139849

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR IMPLANT DATE:| SCS LEAD: MODEL 3219