BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 2802958 · Received October 19, 2012

    Report

    Report Number
    1627487-2012-00686
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES: 11627487-07262012-002-R. 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 ((B)(6)) IS EXPERIENCING DIFFICULTY ESTABLISHING COMMUNICATION WITH THE IPG VIA THE CHARGING SYSTEM. THE PT HAS ALLEGEDLY GAINED WEIGHT AND THE IMPLANT DEPTH OF THE IPG IS NOW MORE PROFOUND. A DECISION REGARDING THE NEXT COURSE OF ACTION HAS NOT BEEN REACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3541082

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention IMPLANT DATE:| SCS LEADS: 3146 (2)