BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE PICOTIP

    MDR report key: 2780121 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12105
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 6, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P950001
    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 THE PATIENT WITH THIS CHRONIC RIGHT VENTRICULAR LEAD UNDERWENT A ROUTINE DEVICE CHANGE OUT PROCEDURE. DURING THE PROCEDURE, THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THAT THE LEAD WOULD NOT CAPTURE AT MAXIMUM OUTPUT. THE LEAD WAS DISCONNECTED AND WHEN TESTED THROUGH THE PACING SYSTEM ANALYZER AND NEW DEVICE, THE LEAD DISPLAYED NORMAL THRESHOLDS. BOSTON SCIENTIFIC TECHNICAL SERVICES DISCUSSED THAT THE CLINICAL OBSERVATIONS MAY BE DUE TO AN INTERMITTENT LEAD FRACTURE. THE PATIENT WILL CONTINUE TO BE MONITORED. THE LEAD REMAINS IN SERVICE. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4034

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 1290| 1273| 4243| 4034