BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 2051195 · Received April 6, 2011

    Report

    Report Number
    1627487-2011-00471
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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 PATIENT WAS IMPLANTED WITH AN IPG. ALTHOUGH HE IS NOT UTILIZING THE IPG FOR PURPOSES OF STIMULATION, THE PATIENT IS REPORTEDLY EXPERIENCING A HEATING SENSATION AT THE IPG POCKET SITE. FOLLOW-UP ON THIS MATTER FOUND THAT THE REPORTED HEATING SENSATION HAS RESOLVED; HOWEVER, THE PATIENT'S IPG WILL BE REMOVED AT A LATER DATE DUE TO HIS NEED FOR AN MRI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG, 16-CHANNEL TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3716 R38329A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention