BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3223719 · Received July 3, 2013

    Report

    Report Number
    1627487-2013-01803
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    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 NUMBER - 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. EVAL CODES, RESULTS: THE COMPLAINT FOR "INEFFECTIVE SIMULATION" WAS CONFIRMED. THE HEADER SHOWED DISCOLORATION. FLUID INTRUSION WAS OBSERVED IN LOWER SEPTUM. THE SEPTA DIDN'T SEEM TO BE CORED, BUT THE ADHESIVE AROUND THE SEPTUM WERE COMING LOSE. INVASIVE CLEANING WAS PERFORMED BY CUTTING THE SILICONE HEADER TO ACCESS THE LOWER BASE OF THE CHANNELS FEED-THROUGH WIRES. AFTER THOROUGH CLEANING, ATE TEST WAS RAN AGAIN AND PASSED ALL FUNCTIONAL TESTS. THE DEVICE WAS PROGRAMMED USING 8 ELECTRODE PAIRS WHILE MONITORING THE STIMULATION OUTPUT; NORMAL STIMULATION WAS OBSERVED ON ALL ELECTRODE PAIRS AND NO EXTRANEOUS STIMULATION WAS OBSERVED. SJM WAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO HE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DETERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-1696.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303838 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2891020

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other