BEUDAMED
    FDA Adverse Event Other Summary report: N

    EON PORT PLUG

    MDR report key: 1971935 · Received January 21, 2011

    Report

    Report Number
    1627487-2011-00130
    Event Type
    Other
    Date Received
    January 21, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 1, 2011
    Manufacturer
    ST. JUDE MEDICAL -NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    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

    DEVICE 2 OF 2. REFERENCE MFR REPORT # 1627487-2011-00129.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON PORT PLUG SPINAL CORD STIMULATION ACCESSORY LGW ST. JUDE MEDICAL -NEUROMODULATION DIV. 1111 175168

    Patients

    Seq Age Sex Outcome Treatment
    1 Other