BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3862846 · Received May 23, 2014

    Report

    Report Number
    1627487-2014-02360
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    March 30, 2014
    Report Date
    September 25, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-012192011-003-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    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 THAT THE PATIENT WAS UNABLE TO COMMUNICATE WITH THE IPG USING HER CHARGER AND PROGRAMMER. PATIENT PROGRAMMER DISPLAYED AN ERROR MESSAGE. PATIENT LOST STIMULATION APPROXIMATELY A MONTH AGO. AN SJM REPRESENTATIVE MET WITH THE PATIENT AND CONFIRMED THE ISSUE. SURGICAL INTERVENTION IS PLANNED AT A LATER DATE TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    FOLLOW-UP REVEALED THE PATIENT'S IPG WAS EXPLANTED AND REPLACED. THE ISSUE WAS RESOLVED BY SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309039 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3175236

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other MODEL: 1192( X2), SCS ANCHOR| IMPLANT DATE:| IMPLANT DATE: