BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2102933 · Received May 4, 2011

    Report

    Report Number
    1627487-2011-00597
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 WAS IMPLANTED WITH AN IPG ON (B)(6) 2010. IT WAS REPORTED THAT HER STIMULATION IS TURNING OFF WITHOUT PROMPTING. A DIAGNOSTIC TEST REVEALED NORMAL IMPEDANCE MEASUREMENTS FOR HER LEAD CONTACTS. IN AN EFFORT TO RESOLVE THIS MATTER, THE PT'S PROGRAMS WERE SET TO MAGNET MODE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG, 16-CHANNEL RECHARGEABLE TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIV. 3788 3126736

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention IMPLANT:| SCS LEAD: MODEL 3186| SCS LEAD EXTENSION: MODEL 3383| IMPLANT: