BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 2843772 · Received November 15, 2012

    Report

    Report Number
    1627487-2012-03723
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    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
    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 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 SHE IS NOT RECEIVING STIMULATION. THE PT'S PROGRAMMER DISPLAYS A COMMUNICATION ERROR AND HER CHARGING SYSTEM IS UNABLE TO LOCATE HER SCS IPG. THE PT HAS NOT CHARGED HER SYSTEM IN MONTHS. THE PT WAS ADVISED OR CHARGING GUIDEWIRES. F/U IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2811031

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention IMPLANT:| SCS LEAD: MODEL 3186| IMPLANT:| SCS EXTENSION: MODEL 3341| SCS LEAD: MODEL 3163 (2)| IMPLANT: