BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET TIP

    MDR report key: 2802713 · Received October 24, 2012

    Report

    Report Number
    2124215-2012-14451
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    NVN
    Adverse Event
    Yes
    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 LEAD WAS BEING EXPLANTED DUE TO NOISE, HIGH IMPEDANCE AND HIGH PACING THRESHOLDS. DURING THIS COMPLEX PROCEDURE, A TEAR IN THE VEIN WAS SUSPECTED AND THE PATIENT LOST A LARGE AMOUNT OF BLOOD, THE HEART RATE INCREASED AND THE BLOOD PRESSURE DROPPED. THE LEAD WAS SURGICALLY ABANDONED. A NEW COMPETITOR LEAD WAS ATTEMPTED BUT WAS UNABLE TO CROSS THE TRICUSPID VALVE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET TIP IMPLANTABLE LEAD NVN HISTORICAL PUERTO RICO 4269

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| L| R 4269| 1297| 4012| K063| 5076| 1230| 5524M