BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1871899 · Received October 16, 2010

    Report

    Report Number
    2124215-2010-17490
    Event Type
    Injury
    Date Received
    October 16, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT PRESENTED TO THE EMERGENCY ROOM WHERE HIS R-WAVES COULD NOT BE MEASURED. THE LEAD IMPEDANCE WAS AT GREATER THAN 2500 OHMS AND THE THRESHOLD WAS GREATER THAN 6.5V. THE PATIENT'S HEART RATE WAS FOUND TO BE VERY LOW AND BEATING IN THE 20'S. THE PATIENT HAD UNDERGONE A DEVICE CHECK 4 DAYS PRIOR AND THE LEAD AND DEVICE CHECKED OUT FINE AT THAT TIME. THE LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS 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 55 YR Required Intervention 4087| 1298| 4088| S603