BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3850735 · Received May 21, 2014

    Report

    Report Number
    1627487-2014-21305
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 THE PATIENT HAD BEEN DEFIBRILLATED A YEAR AGO, AND SINCE THEN HE HAS NOT USED THE SCS SYSTEM. THE PATIENT HAS MULTIPLE HEALTH ISSUES THAT CANNOT BE DIAGNOSED DUE TO THE MRI RESTRICTION ON THE SCS SYSTEM. THE PATIENT'S HEALTH CARE PROVIDERS RECOMMENDED THE SCS SYSTEM BE EXPLANTED TO ADDRESS HIS OTHER HEALTH ISSUES. THE PATIENT WILL CONSULT WITH THE IMPLANTING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303452 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 2876099

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other IMPLANT:| SCS LEAD: MODEL 3219