BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIPASS

    MDR report key: 3212594 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10369
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 16, 2013
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    PMA / PMN Number
    P890039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WILL CONTINUE TO BE MONITORED VIA REMOTE MONITORING. 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 THIS PACEMAKER AND LEAD EXHIBITED OVERSENSED NOISE ON THE RIGHT VENTRICULAR AND RIGHT ATRIAL CHANNELS. THE PATIENT WAS SEEN IN CLINIC AND NOISE COULD BE RECREATED. IT WAS REPORTED THE PATIENT IS PACER DEPENDENT. THE SENSITIVITY WAS REPROGRAMMED ON BOTH CHANNELS AND NO FURTHER NOISE WAS OBSERVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311944 UNIPASS IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 425-04

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR 292-06| 425-04| K063| 1276