BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THINLINE

    MDR report key: 2041649 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01285
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT POST AN EXTERNAL CARDIOVERSION FOR ATRIAL FLUTTER, THREE SECONDS OF ASYSTOLE WAS OBSERVED WITH THIS PACEMAKER AND ALSO INCREASED RIGHT VENTRICULAR THRESHOLD MEASUREMENTS WERE NOTED. THE CALLER WAS UNABLE TO OBTAIN IMPEDANCES MEASUREMENTS AT FIRST, HOWEVER THIS ISSUE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THINLINE IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 430-10-52

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR (B)(4)| 1273| (B)(4)| 1296