BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1871133 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17358
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    CPI - DEL CARIBE
    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

    THIS LEAD WAS SURGICALLY ABANDONED AND WILL NOT BE RETURNED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS, NO SENSING AND LOSS OF CAPTURE (LOC). THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH PRE-SYNCOPE AND COMPLETE HEART BLOCK WITH AN ESCAPE RHYTHM OF 30 BEATS PER MINUTE (BPM) OBSERVED. A LEAD FRACTURE WAS NOTED AND A LEAD REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. OTHER THAN THE PROCEDURE, NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening| R 1291| 4088| 4087