BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3171881 · Received June 7, 2013

    Report

    Report Number
    1627487-2013-05805
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    May 14, 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
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL NUMBER: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER IS 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 PATIENT'S IPG IS NON-FUNCTIONAL DUE TO THE PATIENT NOT MAINTAINING THE IPG AS RECOMMENDED. AN SJM REPRESENTATIVE MET WITH THE PATIENT AND CONFIRMED THE IPG IS INOPERABLE, AND WILL NOT COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, THE PATIENT WILL UNDERGO SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253680 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 173276

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCS LEAD, MODEL: 3186| SCS EXTENSION: MODEL: 3383| IMPLANT:| IMPLANT: