BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 1961069 · Received January 12, 2011

    Report

    Report Number
    1627487-2011-00056
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 RECEIVED HIS SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT HE IS WITHOUT STIMULATION AND UNABLE TO COMMUNICATE WITH HIS IPG USING EITHER THE PROGRAMMER OR CHARGING SYSTEM. EFFORTS TO RECAPTURE EFFECTIVE STIMULATION WITH THE USE OF A REPLACEMENT PROGRAMMER AND CHARGING SYSTEM PROVED UNSUCCESSFUL. THE PT'S IPG WAS REPLACED ON (B)(6) 2011 AND EFFECTIVE STIMULATION WAS RECAPTURED. THE EXPLANTED DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3788 2867471

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention