BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG

    MDR report key: 1924715 · Received December 9, 2010

    Report

    Report Number
    1627487-2010-03472
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 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
    OH, 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 WAS IMPLANTED WITH AN IPG ON (B)(6) 2010. IT WAS REPORTED THAT SHE WAS UNABLE TO COMMUNICATE WITH THE DEVICE USING MULTIPLE PROGRAMMERS AND CHARGING SYSTEMS. THE IPG WAS REPLACED ON (B)(6) 2010 AND HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. FOLLOW-UP ON THE PT FOUND NO OTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3788 2881387

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention