BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4202556 · Received October 22, 2014

    Report

    Report Number
    1627487-2014-21680
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    January 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIONS/REMOVAL REPORTING NUMBER: 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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 ((B)(6)) HAD NOT CHARGED THE IPG IN APPROXIMATELY NINE MONTHS. SUBSEQUENTLY, SURGICAL INTERVENTION TOOK PLACE TO EXPLANT AND REPLACE THE IPG. THE PT IS RECEIVING EFFECTIVE STIMULATION POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674138 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 2770076

    Patients

    Seq Age Sex Outcome Treatment
    1 Other