BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTEGE

    MDR report key: 4251011 · Received November 5, 2014

    Report

    Report Number
    1627487-2014-08414
    Event Type
    Death
    Date Received
    November 5, 2014
    Date of Event
    October 11, 2014
    Report Date
    October 17, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SJM HAS LIMITED INFO RELATED TO THE PATIENT'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

    IT WAS REPORTED THE PT PASSED AWAY. THE PT'S PHYSICIAN DID NOT HAVE A CONFIRMATION OF THE CAUSE OF DEATH ND NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710431 PROTEGE SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3789 4765062

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death SCS LEAD: MODEL 3186 (X2)| SCS ANCHOR: MODEL 1192 (X2)| IMPLANTED:| IMPLANTED: