BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4151841 · Received October 6, 2014

    Report

    Report Number
    1627487-2014-20285
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    March 1, 2014
    Report Date
    September 15, 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

    CORRECTIONS/REMOVAL REPORTING NUMBER: 1627487-07262012-002-R AND 1627487-12192011-003-R. THESE IPG SERIAL NUMBERS WERE 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

    IT WAS REPORTED THE PATIENT EXPERIENCED LOSS OF STIMULATION AS THE PATIENT HAD NOT RECHARGED HER IPG FOR ABOUT 6 MONTHS. THE SJM REPRESENTATIVE CONFIRMED THE IPG IS INOPERABLE. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622405 EON MINI SCS IPG GZB ST. JUDE MEDICAL ¿ NEUROMODULATION 3788 3199510

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other IMPLANT:| SCS LEAD: MODEL 3219