BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2062156 · Received March 17, 2011

    Report

    Report Number
    1627487-2011-00366
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    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

    THIS REPORT IS BEING SUBMITTED AS A PRECAUTIONARY MEASURE, AS SIMILARLY REPORTED EVENTS HAVE LED TO THE EXPLANT OF THE IPG. 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

    THE PT WAS IMPLANTED WITH AN IPG ON (B)(6) 2009. IT WAS REPORTED THAT SHE IS WITHOUT STIMULATION AND UNABLE TO COMMUNICATE WITH THE IPG VIA EITHER THE PROGRAMMER OR THE CHARGING SYSTEM. IN AN EFFORT TO RESOLVE THIS MATTER, A REPLACEMENT CHARGING SYSTEM WAS SHIPPED TO THE PT. FOLLOW-UP ON THIS ISSUE FOUND THAT THE REPORTED PROBLEM PERSISTS. THE PT IS CONCERNED THAT HER STIMULATION ISSUE MAY BE RELATED TO HER RECENT WEIGHT LOSS. AN APPOINTMENT HAS BEEN SCHEDULED FOR FURTHER INTERROGATION OF THE PT'S SCS SYSTEM.

    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 2852894

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention