BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3952527 · Received May 15, 2014

    Report

    Report Number
    1627487-2014-01312
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ST JUDE MEDICAL NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS WITHOUT STIMULATION AND IS UNABLE TO RECHARGE THE IPG. A COMMUNICATION ERROR MESSAGE DISPLAYED ON THE PATIENT PROGRAMMER. THE SJM REPRESENTATIVE WILL CONTACT THE PATIENT AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290674 EON MINI SCS IPG GZB ST JUDE MEDICAL NEUROMODULATION 3788 2810781

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR SCS LEAD: MODEL 3219,| IMPLANT DATE: