BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRODE - DBS

    MDR report key: 3111802 · Received May 7, 2013

    Report

    Report Number
    1627487-2013-00255
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT APPROVED FOR SALE IN THE USA, BUT IS SIMILAR TO A USA MARKETED/APPROVED DEVICE. 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

    DURING A DBS SYSTEM IMPLANTATION IN AUSTRALIA, IT WAS REPORTED THE PHYSICIAN EXPERIENCED DIFFICULTY REMOVING THE LEADS FROM THE PLASTIC TUBING. THE DEVICES BECAME STUCK AND REQUIRED MANIPULATION IN ORDER TO EXTRACT. NO VISIBLE DEVICE DAMAGE WAS DETECTED UPON REMOVAL AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199903 QUATTRODE - DBS DBS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 6145 3451309

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention