BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 2900787 · Received December 12, 2012

    Report

    Report Number
    1627487-2012-11810
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 20, 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
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS 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 HAD NOT CHARGED FOR IPG IN OVER A YEAR. THE SJM REP MET WITH THE PT AND CONFIRMED THE IPG WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. IT WAS REPORTED THE PT WAS TO F/U WITH HER PHYSICIAN REGARDING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3410795

    Patients

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