BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 2173677 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10545
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THIS LEAD WAS SURGICALLY ABANDONED, BOSTON SCIENTIFIC CANNOT CONFIRM NOR DENY THIS REPORTED CLINICAL ALLEGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE REPLACEMENT PROCEDURE, INTERROGATION OF THIS ATRIAL LEAD REVEALED HIGH OUT OF RANGE IMPEDANCE MEASUREMENT. THIS MEASUREMENT HAD INCREASED DURING THE PAST TWO MONTHS. IN ADDITION, NOISE AND INCREASED THRESHOLD MEASUREMENTS WERE NOTED. IT WAS THOUGHT THERE MAY BE A LEAD FRACTURE. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention