BEUDAMED
    FDA Adverse Event Death Summary report: N

    OCTRODE

    MDR report key: 2891094 · Received December 21, 2012

    Report

    Report Number
    1627487-2012-13257
    Event Type
    Death
    Date Received
    December 21, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 28, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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

    IT WAS REPORTED THE PT HAD COMPLETED A SUCCESSFUL SCS TRIAL PERIOD ON (B)(6) 2012 AND THE LEADS WERE REMOVED. IT WAS ALSO REPORTED THE PT HAD PASSED AWAY FROM UNK CAUSES. NO FURTHER INFO IS AVAILABLE AT THIS TIME. F/U PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3818190

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death