BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3960407 · Received July 17, 2014

    Report

    Report Number
    1627487-2014-23470
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 23, 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

    CORRECTION/REMOVAL NUMBER: 1627487-12192011-003-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

    IT WAS REPORTED THE PATIENT IS UNABLE TO ESTABLISH COMMUNICATION BETWEEN HER IPG AND EXTERNAL DEVICES. THE PATIENT'S PROGRAMMER ALSO DISPLAYS A COMMUNICATION ERROR. IT WAS ALSO REPORTED THE PATIENT HAS NOT CHARGED THE IPG IN APPROXIMATELY 10 MONTHS. THE PATIENT IS WITHOUT STIMULATION. THE PATIENT WILL UNDERGO SURGICAL INTERVENTION TO ADDRESS THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420340 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 2826526

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other IMPLANT DATE:| SCS LEAD: MODEL 3186(3)| IMPLANT DATE:| SCS EXTENSION: MODEL 3383