BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IMPLANTABLE PULSE GENERATOR

    MDR report key: 2073643 · Received April 13, 2011

    Report

    Report Number
    1627487-2011-02438
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    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 RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2010. IT WAS REPORTED THE PT WAS EXPERIENCING HEATING AT THE IPG SITE WHILE CHARGING. A NEW CHARGING SYSTEM WAS SENT TO THE PT AND RESOLVED THE HEATING ISSUE. THE IPG REMAINS IN USE. NO FURTHER PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    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 2874316

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention