BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2781082 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13197
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 20, 2012
    Report Date
    May 14, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    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 ATRIAL (RA) LEAD EXHIBITED AN OUT OF RANGE PACING IMPEDANCE MEASUREMENT. REVIEW OF MEASUREMENTS SHOWED A DOWNWARD TREND FROM 700 OHMS TO 420 OHMS. IN CLINIC THE LEAD WAS CHECKED IN UNIPOLAR AND BIPOLAR. BOTH CONFIGURATIONS REVEALED PACING IMPEDANCE MEASUREMENTS OF 500 OHMS. IN UNIPOLAR INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) MODE SWITCHES WERE OBSERVED. THE PHYSICIAN ELECTED TO PROGRAM THE LEAD TO BIPOLAR AND WILL CONTINUE TO MONITOR. NO ADVERSE PATIENT EFFECTS OR SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT IMPLANTED WITH THIS RA LEAD UNDERWENT A DEVICE REPLACEMENT PROCEDURE. THIS LEAD WAS FOUND TO BE FRACTURED. NOISE WAS ALSO NOTED PRIOR TO THE PROCEDURE. NO ADDITIONAL 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 79 YR Hospitalization| L| R 1291| 4088| 4087