BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET TIP

    MDR report key: 2040930 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00719
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    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 THIS RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE ON THE ATRIAL CHANNEL. IT WAS NOTED THAT THE NOISE COULD NOT BE RECREATED. POSSIBLE CAUSES FOR THE NOISE WERE QUESTIONED, AS WELL AS IF THIS LEAD WOULD BE OKAY TO USE WITH THE NEW DEVICE, AS THE PATIENT WAS TO HAVE A DEVICE REPLACEMENT. IT WAS NOTED THAT ALL OTHER LEAD MEASUREMENTS WERE STABLE. TECHNICAL SERVICES (TS) DISCUSSED POSSIBLE CAUSES AND RECOMMENDED TROUBLESHOOTING OPTIONS. DURING THE DEVICE REPLACEMENT PROCEDURE, IT WAS NOTED THAT WHEN THIS LEAD WAS REMOVED FROM THE DEVICE HEADER, BECAME SEPARATED AT THE TERMINAL PIN. THE LEAD WAS SURGICALLY CAPPED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET TIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4269

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR 4269| E110| 0125| 1821| 4136| 1861