BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3113046 · Received May 10, 2013

    Report

    Report Number
    1627487-2013-12651
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 WAS INCLUDED IN A FIELD ADVISORY. 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 PT DID NOT USE OF CHARGE THE SCS SYSTEM FOR SEVERAL MONTHS. THE IPG CANNOT COMMUNICATE WITH THE EXTERNAL DEVICES DUE TO BATTERY DEPLETION. THE PT IS WITHOUT STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205556 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3234926

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention SCS LEAD, MODEL 3228| IMPLANT DATE: