BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4173841 · Received October 10, 2014

    Report

    Report Number
    1627487-2014-05696
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    ST. JUDE MEDICAL ¿ NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD ADVISORY. 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 DID NOT RECHARGE HER IPG AS RECOMMENDED. IN TURN, SHE LOST STIMULATION DUE TO THE IPG BECOMING INOPERABLE. AS A RESULT, THE PATIENT'S IPG WAS EXPLANTED AND REPLACED (WITH A DIFFERENT MODEL). STIMULATION WAS RESTORED POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643049 EON MINI SCS IPG GZB ST. JUDE MEDICAL ¿ NEUROMODULATION 3788 3486376

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other IMPLANT:| SCS LEAD: MODEL 3286| SCS ANCHORS: MODEL 1192 (X2)| SCS LEAD: MODEL 3186| IMPLANT:| IMPLANT: