BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3820934 · Received May 12, 2014

    Report

    Report Number
    1627487-2014-05332
    Event Type
    Injury
    Date Received
    May 12, 2014
    Date of Event
    March 26, 2014
    Report Date
    April 18, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT#: 1627487-2014-05333. IT WAS REPORTED, THE PT WAS EXPERIENCING NERVE PAIN AT THE IPG SITE AND IN HIS RIGHT LEG. IN TURN, THE PT UNDERWENT SURGICAL INTERVENTION. DURING THE PROCEDURE, THE LEAD WAS FOUND TO BE SLIGHTLY DISCONNECTED FROM THE HEADER OF THE IPG. LEAD MIGRATION WAS ALSO FOUND. THE DOCTOR DECIDED TO EXPLANT AND REPLACE THE IPG (WITH A DIFFERENT MODEL). THE LEAD WAS LEFT WHERE IT HAD MIGRATED. POST-OP, THE SCS SYSTEM PERFORMED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284106 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3715792

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other IMPLANT:| SCS ANCHOR: MODEL 1192