BEUDAMED
    FDA Adverse Event Death Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2023159 · Received March 16, 2011

    Report

    Report Number
    1627487-2011-00350
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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

    DEVICE 1 OF 2. REFERENCE MFR. REPORT # 1627487-2011-00361. THE PATIENT'S SCS SYSTEM WAS IMPLANTED ON (B)(6) 2010 AND CONSISTED OF AN IPG AND SURGICAL LEAD. ON (B)(6) 2011, IT WAS REPORTED THAT THE PATIENT HAD PASSED AWAY. NO DETAILS AS TO THE CAUSE OF DEATH WERE PROVIDED AT THAT TIME. THE MANUFACTURER WAS UNABLE TO OBTAIN ADDITIONAL INFORMATION RELATED TO THIS MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG, 16-CHANNEL RECHARGEABLE TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIV 3788 3170754

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death