BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1874735 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17660
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 6, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, INTERROGATION REVEALED THIS RIGHT VENTRICULAR LEAD TRIGGERED A LEAD SAFETY SWITCH TO OCCUR AS A RESULT OF HIGH IMPEDANCE MEASUREMENTS. IN ADDITION, LOSS OF CAPTURE WAS DISPLAYED. ALL OTHER LEAD MEASUREMENTS WERE WITHIN NORMAL MEASUREMENTS, HOWEVER A DECISION HAS BEEN MADE TO REPLACE THIS LEAD. THE PATIENT WITH THIS LEAD HAS AN INTRINSIC HEART BLOCK CARDIAC RHYTHM. 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