BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3850639 · Received May 29, 2014

    Report

    Report Number
    1627487-2014-26459
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 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 INFO 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 DURING THE PERMANENT PROCEDURE, THE FIRST LEAD WAS PLACED AND ALL CONTACTS WERE INVALID. THE PT DID NOT FEEL ANY STIMULATION. THE CONNECTIONS WERE CHECKED, LEAD REPOSITIONED AND THE MTS WAS SWITCHED TO NO AVAIL. SUBSEQUENTLY, THE LEAD WAS REMOVED. A NEW LEAD WAS USED TO COMPLETE THE PROCEDURE AND THE PT RECEIVED EFFECTIVE STIMULATION AND THE IMPEDANCE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317197 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3153 4240095

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other