BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IMPLANTABLE PULSE GENERATOR

    MDR report key: 2092684 · Received May 10, 2011

    Report

    Report Number
    1627487-2011-02581
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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

    DEVICE 1 OF 4. REFERENCE MANUFACTURER REPORT: 1627487-2011-02582, 1627487-2011-02583 AND 1627487-2011-02584. THE PT RECEIVED AN SCS SYSTEM WHICH INCLUDED AN IPG AND THREE PERCUTANEOUS LEADS. IT WAS REPORTED THE SCS SYSTEM WAS EXPLANTED AND NOT REPLACED DUE TO INEFFECTIVE STIMULATION. UPON OPENING THE IPG POCKET, THE PHYSICIAN NOTED THAT ONE OF THE LEADS HAD BECOME DISCONNECTED FROM THE IPG. IT WAS UNK WHEN OR HOW THE LEAD DISCONNECTED FROM THE IPG. 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 3126738

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention