BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2093169 · Received April 14, 2011

    Report

    Report Number
    1627487-2011-00522
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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

    THE PT WAS IMPLANTED WITH AN IPG ON (B)(6) 2010. IT WAS REPORTED THAT HER STIMULATION TURNS OFF SHORTLY AFTER COMMUNICATION IS ESTABLISHED BETWEEN HER IPG AND PROGRAMMER. IN AN EFFORT TO RESOLVE THIS MATTER, A NEW PROGRAMMER WAS SHIPPED TO THE PT. F/U ON THIS ISSUE FOUND THAT THE REPORTED PROBLEM PERSISTS WITH USE OF HER REPLACEMENT PROGRAMMER. ADD'L TROUBLESHOOTING WILL BE CONDUCTED.

    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 DIVISION 3788 3175236

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention