BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3950294 · Received June 19, 2014

    Report

    Report Number
    1627487-2014-02442
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 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 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 2 OF 2. REFERENCE MFR REPORT: 1627487-2014-02441. I WAS REPORTED THE PATIENT'S SCS TRIAL PROCEDURE WAS ABANDONED THE PATIENT HAD EXCESSIVE BLEEDING AT THE NEEDLE INSERTION SITE. THE PHYSICIAN SUSPECTED A POSSIBLE HEMATOMA AND ORDERED AN MRI. THE MRI CONFIRMED THERE WAS NO HEMATOMA. IN ADDITION, IMPEDANCE ISSUES WERE ENCOUNTERED AND EFFECTIVE STIMULATION COULD NOT BE ACHIEVED DURING INTRAOP TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360869 OCTRODE SCS LEAD GZB ST.JUDE MEDICAL - NEUROMODULATION 3086 4550146

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other