BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2171321 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-09983
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IN SERVICE. 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 VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE FOR AN UNKNOWN DURATION. IMPEDANCE MEASUREMENTS WERE LESS THAN 200 OHMS. THE DEVICE WAS PROGRAMMED TO AAI. DURING A ROUTINE DEVICE CHANGEOUT PROCEDURE, THE CHRONIC RV LEAD WAS SURGICALLY ABANDONED AND REPLACED WITHOUT COMPLICATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    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 84 YR Hospitalization| R 1290| 4088| 4087