BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1944677 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-20338
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW RIGHT VENTRICULAR LEAD WAS SUCCESSFULLY IMPLANTED. THE ABANDONED LEAD WAS NOT RETURNED FOR ANALYSIS; THEREFORE, THE CLINICAL OBSERVATIONS COULD NOT BE CONFIRMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AN AMENDED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS RIGHT VENTRICULAR LEAD EXHIBITED IMPEDANCES GREATER THAN 2,500 OHMS AND LOSS OF CAPTURE AT MAXIUMU OUTPUTS. A REVIEW OF THE DAILY MEASUREMENTS REVEALED THAT THE VENTRICULAR LEAD IMPEDANCES HAD BEEN GREATER THAN 2,500 OHMS SINCE (B)(6), 2010. DURING THE ROUTINE DEVICE REPLACEMENT PROCEDURE; THE RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED AND REPLACED. DURING THE PROCEDURE, THERE WAS NO OBVIOUS SIGNS OF A LEAD FRACTURE OR CONNECTION ISSUE. 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 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R