BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2173693 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10764
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO ADDITIONAL INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED OR IF THE LEAD IS EXPLANTED AND RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS ELECTIVELY CAPPED AND SURGICALLY ABANDONED AFTER A HISTORY OF LOW IMPEDANCE MEASUREMENTS, NOISE, AND INTERMITTENT LOSS OF CAPTURE. THERE WERE NO ADVERSE PATIENT EFFECTS BEYOND THE SURGICAL PROCEDURE. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THAT THERE WAS EVIDENCE OF LEAD INSULATION DEGRADATION, AND THE ASSOCIATED DEVICE HAD STORED ABOUT 1800 NON-SUSTAINED VENTRICULAR TACHYCARDIA (VT) EPISODES. ISOMETRIC EXERCISES WERE NEGATIVE, AND PACE THRESHOLD MEASUREMENTS WERE NORMAL. EXIT BLOCK WAS ALSO BEING CONSIDERED AS A CONTRIBUTING FACTOR.

    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 70 YR Required Intervention 4087| 4086| 1298