BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLAIM 8

    MDR report key: 4142830 · Received September 23, 2014

    Report

    Report Number
    1627487-2014-06292
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    August 29, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    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 4 OF 5. REFERENCE MFR REPORT: 1627487-2014-06289, 06290, 06291, 06293.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591083 EXCLAIM 8 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3225 3736535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other