BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2172928 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11461
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    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

    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 PACING LEAD EXHIBITED NOISE AND LOSS OF CAPTURE. PACING IMPEDANCE MEASUREMENTS LESS THAN 100 OHMS WERE ALSO NOTED. THERE WAS NO ASYSTOLE AS THE PATIENT HAS AN UNDERLYING RHYTHM. A LEAD FRACTURE WAS SUSPECTED. IT WAS REPORTED THE PATIENT EXPERIENCED MUSCLE STIMULATION. AN INVASIVE PROCEDURE WAS PERFORMED. THIS LEAD WAS CAPPED AND SURGICALLY ABANDONED. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. 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 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention 4087| 1290| 4457| (B)(4)| S603