BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16-CHANNEL RECHARGEABLE IPG

    MDR report key: 2193107 · Received July 21, 2011

    Report

    Report Number
    1627487-2011-04004
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SERIAL NUMBER IS ASSOCIATED WITH A FIELD ADVISORY. 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) 2009. THE PT REPORTED FEELING A BURNING SENSATION AROUND THE IPG WHETHER THE STIMULATION IS ON OR OFF, AND EVEN AFTER TURNING THE IPG OFF FOR SEVERAL HOURS. ATTEMPTS TO FOLLOW-UP WITH THE PT AND NEXT COURSE OF ACTION HAVE BEEN UNSUCCESSFUL. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2746103

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention IMPLANT:| SCS LEAD: MODEL 3181 (2)