BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL EXTENSION

    MDR report key: 4143047 · Received September 11, 2014

    Report

    Report Number
    1627487-2014-02639
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    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

    IT WAS REPORTED DURING THE PATIENT'S PERMANENT PROCEDURE TO IMPLANT HER SCS SYSTEM, HIGH IMPEDANCES WERE OBSERVED. THE PATIENT'S SCS LEAD EXTENSION READ HIGH IMPEDANCE FOR MULTIPLE CONTACTS WHEN TESTED INTRA-OPERATIVELY. THE PHYSICIAN USED ANOTHER EXTENSION AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS REPORTEDLY EXTENDED BY APPROXIMATELY FIVE MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563328 DUAL EXTENSION SCS EXTENSION GZB ST. JUDE MEDICAL - NEUROMODULATION 3346 4559061

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR