BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3960395 · Received July 17, 2014

    Report

    Report Number
    1627487-2014-21482
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2014-21483. IT WAS REPORTED PRIOR TO TESTING THE PATIENT'S (B)(6) LEADS INTRA-OPERATIVELY, IT WAS NOTICED THAT THE PATIENT'S OXYGEN LEVELS DROPPED AND THE PATIENT BECAME UNRESPONSIVE AND HYPERSENSITIVE. THE PHYSICIAN PULLED THE PATIENT'S LEADS OUT, TURNED THE PATIENT TO A SUPINE POSITION AND REVIVED THE PATIENT. THE PATIENT WAS MONITORED IN AN INTENSIVE CARE UNIT AND IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420331 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4486884

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization