BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 2852351 · Received November 13, 2012

    Report

    Report Number
    1627487-2012-06750
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 19, 2012
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-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 IS INCLUDED IN A FIELD ADVISORY. SJM HAS LIMITED INFO 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

    IT WAS REPORTED THE PT HAS LOST STIMULATION. IT WAS ALSO REPORTED THE PROGRAMMER CAN NO LONGER COMMUNICATE WITH THE IPG. A NEW PROGRAMMER WAS SENT TO THE PT. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL NEUROMODULATION 3788 3395280

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention SCS LEAD: MODEL 3288| IMPLANT DATE: