BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IMPLANTABLE PULSE GENERATOR

    MDR report key: 2062183 · Received March 17, 2011

    Report

    Report Number
    1627487-2011-02336
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 HIS SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2011. IT WAS REPORTED THE PT CANNOT ELICIT A RESPONSE FROM HIS IPG WHEN USING THE IPG MAGNET. ATTEMPTS TO OBTAIN ADDITIONAL INFO REGARDING THE PT'S CONDITION AND/OR DEVICE STATUS WERE UNSUCCESSFUL. NO 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 3170768

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention SCS LEAD: MODEL 3245| SCS LEAD EXTENSION: MODEL 3183| IMPLANT:| SCS LEAD: MODEL 3245| IMPLANT:| IMPLANT: