BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3850654 · Received May 29, 2014

    Report

    Report Number
    1627487-2014-15414
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    May 1, 2012
    Report Date
    May 8, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. SJM HAS LIMITED INFO 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 WAS WITHOUT STIMULATION AND HER IPG WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. THE PATIENT STATED SHE HAS NOT CHARGED HER IPG IN 2 YEARS. THE SJM REPRESENTATIVE MET WITH THE PATIENT AND VERIFIED THE ISSUE. PATIENT IS TO CONSULT WITH HER PHYSICIAN REGARDING UNDERGOING SURGICAL INTERVENTION AT A LATER DATE AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317199 EON MINI SCS IPG GZB ST. JUDE MEDICAL, NEUROMODULATION 3788 2893988

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other SCS LEAD, MODEL 3219| IMPLANT DATE: