BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IMPLANTABLE PULSE GENERATOR

    MDR report key: 1910320 · Received November 18, 2010

    Report

    Report Number
    1627487-2010-03572
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 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
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: EVAL SUMMARY: THE IPG WAS NOT RETURNED TO THE MFR FOR ANALYSIS. AS A RESULT, THE DEVICE HISTORY AND STERILIZATION RECORDS FOR THE IPG ARE CURRENTLY UNDER REVIEW. THE RESULTS OF THE REVIEW 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 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 HER SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2010. IT WAS REPORTED THE IPG WILL BE SURGICALLY REPOSITIONED AS IT IS CURRENTLY IMPLANTED TOO DEEPLY. AS A RESULT OF THE IMPLANT SITE, TELEMETRY CANNOT BE ESTABLISHED WITH THE IPG. THE IPG WILL BE REIMPLANTED; THEREFORE, NO PRODUCT RETURN IS EXPECTED. F/U 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 3175230

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention