BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2881399 · Received December 17, 2012

    Report

    Report Number
    1627487-2012-03870
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    November 17, 2012
    Report Date
    November 19, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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

    IT WAS REPORTED THE PT RECEIVED IPG NO TELEMETRY AND COMMUNICATION PRIOR MESSAGES FROM THE HER PT PROGRAMMER. ADDITIONALLY, THE PT'S CHARGING SYSTEM COULD ONLY ATTAIN A FLASHING YELLOW LIGHT. F/U IDENTIFIED THE PT HAD STOPPED RECEIVING STIMULATION. SUBSEQUENT, THE PT'S SCS IPG WAS REPLACED AND AIR ISSUES HAVE BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3416830

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3228