BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4024298 · Received August 13, 2014

    Report

    Report Number
    1627487-2014-03531
    Event Type
    Injury
    Date Received
    August 13, 2014
    Date of Event
    May 25, 2014
    Report Date
    July 25, 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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL: 1627487-12192011-003-R, 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

    THE PATIENT REPORTED SHE IS UNABLE TO ESTABLISH COMMUNICATION BETWEEN HER SCS IPG AND EXTERNAL DEVICES AND ALLEGES SHE LAST SUCCESSFULLY CHARGED 2 MONTHS AGO. THE PATIENT IS NOT LONGER RECEIVING STIMULATION. AN SJM REPRESENTATIVE CONFIRMED THE ISSUES. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482929 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 2749510

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR IMPLANT DATE:| SCS LEAD: MODEL 3228