BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4252642 · Received November 5, 2014

    Report

    Report Number
    1627487-2014-20404
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    ST JUDE MED - 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

    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'S TRIAL PROCEDURE WAS ABANDONED AS THE PT'S HEART RATE AND BLOOD PRESSURE DROPPED DURING THE PROCEDURE. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. THE PT WAS TO BE IMPLANTED WITH TWO SCS LEADS WITH THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710199 OCTRODE SCS LEAD GZB ST JUDE MED - NEUROMODULATION 3086 4434318

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other