BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IMPLANTABLE PULSE GENERATOR

    MDR report key: 1993691 · Received January 6, 2011

    Report

    Report Number
    1627487-2011-02025
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 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
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 PT RECEIVED AN SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2010. DURING AN ELECTIVE LEAD UPGRADE, THE PHYSICIAN REMOVED THE IMPLANTED LEADS FROM THE TISSUE. WHILE DOING SO, THE LEAD INADVERTENTLY CAME OUT OF THE IPG HEADER. ACCORDING TO THE PHYSICIAN, THE SETSCREWS HAD NOT BEEN LOOSENED AT THAT POINT. AS A RESULT, THE IPG WAS EXPLANTED AND REPLACED. THE EXPLANTED IPG WAS NOT 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 2826363

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention