BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THINLINE

    MDR report key: 3212997 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10137
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 FOUR DAYS POST IMPLANT, NOISE/OVERSENSING WITH HIGH OUT OF RANGE PACING IMPEDANCES MEASUREMENTS, WERE OBSERVED WITH THIS LEAD RIGHT ATRIAL LEAD. THE PHYSICIAN SUSPECTED A LOOSE PIN (CONNECTION ANOMALY) AND CONSEQUENTLY, REPROGRAMMED THE ASSOCIATED DEVICE TO VVI. NO ADVERSE PATIENT EFFECTS REPORTED DUE TO THE LOSE OF ATRIAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312424 THINLINE IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 432-04

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR 430-10| 432-04| 284-05