BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3960653 · Received June 20, 2014

    Report

    Report Number
    1627487-2014-05448
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED STIMULATION TURNED OFF BEFORE AND DURING A NON-RELATED SURGERY. AFTER THE PROCEDURE, STIMULATION COULD NOT BE RESTORED DUE TO THE PROGRAMMER AND CHARGER BEING UNABLE TO COMMUNICATE WITH THE IPG. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PATIENT, BUT DID NOT PROVIDE RESOLUTION. AS A RESULT, THE PATIENT WILL UNDERGO SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362527 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3218900

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR IMPLANT DATE:| SCS LEAD: MODEL 3228