BEUDAMED
    FDA Adverse Event Death Summary report: N

    EON MINI

    MDR report key: 3111168 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-06269
    Event Type
    Death
    Date Received
    May 9, 2013
    Date of Event
    March 17, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    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

    IT WAS REPORTED BY THE PATIENT'S HUSBAND THAT SHE PASSED AWAY. THE PHYSICIAN'S OFFICE WAS CONTACTED FOR ADDITIONAL INFORMATION, BUT NO FURTHER INFORMATION WAS OBTAINED. IT IS UNKNOWN IF THE PATIENT'S DEVICES WERE STILL IMPLANTED AT THE TIME OF THE PATIENT'S DEATH. IT IS UNKNOWN IF ANY DEVICES WILL BE RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205038 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3597323

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death SCS LEAD: MODEL 3186 (X2)| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (X2)| IMPLANT DATE: