BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IMPLANTABLE PULSE GENERATOR

    MDR report key: 1910929 · Received November 23, 2010

    Report

    Report Number
    1627487-2010-03627
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. SJM HAS LIMITED INFO RELATED TO THE PT'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 PT RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2010. IT WAS REPORTED THAT THE PT EXPERIENCED A SUDDEN LOSS OF STIMULATION. IN AN ATTEMPT TO TROUBLESHOOT THE PROBLEM, THE PT, USING BOTH HIS PT PROGRAMMER AND CHARGING SYSTEM, TRIED TO LOCATE HIS IPG. UNFORTUNATELY, NO RESPONSE COULD BE ELICITED FROM THE IPG. THE IPG WAS EXPLANTED AND REPLACED. THE EXPLANTED IPG WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. FOLLOW UP ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2891069

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention