BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3963630 · Received May 19, 2014

    Report

    Report Number
    1627487-2014-25389
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 28, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL: 1627487-12192011-003-R, 1627487-07262012-002-R. THIS IPG SERIAL NUMBER IS 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

    THE PATIENT REPORTED THE CHARGER AND PROGRAMMER ARE UNABLE TO COMMUNICATE WITH THE IPG. ADDITIONALLY, THE PATIENT REPORTED HE HAS NOT USED THE SYSTEM IN OVER A MONTH DUE TO NOT HAVING ANY PAIN. AS A RESULT, THE IPG IS INOPERABLE. AN SJM REPRESENTATIVE MET WITH THE PATIENT AND CONFIRMED A REPLACEMENT PROGRAMMER AND CHARGER ARE UNABLE TO COMMUNICATE WITH THE IPG. THE PATIENT WILL CONSULT WITH HIS PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296439 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 2796641

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR SCS LEAD: MODEL 3219| IMPLANT DATE: