BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3113296 · Received April 25, 2013

    Report

    Report Number
    1627487-2013-13639
    Event Type
    Malfunction
    Date Received
    April 25, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R,
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL NUMBER: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT REPORTED HE LOST STIMULATION AND WAS NO LONGER ABLE TO COMMUNICATE WITH HIS IPG USING EITHER THE PROGRAMMER OR CHARGING SYSTEM. THE PT STATED HE USUALLY CHARGES ONCE A MONTH FOR APPROXIMATELY 2 HOURS. HE ALSO STATED HE HAS NEVER LOST STIMULATION BEFORE, EVEN AFTER NOT CHARGING FOR A MONTH. A NEW CHARGER WAS SENT TO THE PT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180113 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2867459

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention SCS LEAD: MODEL: 3166 (2)| SCS LEAD: MODEL: 3262| IMPLANT DATE:| IMPLANT DATE: