BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3210110 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07290
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 14, 2013
    Report Date
    April 15, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ABANDONED RIGHT ATRIAL (RA) LEAD WILL NOT BE RETURNED TO BOSTON SCIENTIFIC THEREFORE, THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED. WHILE THE DEVICE WAS RETURNED FOR ANALYSIS TO BE ANALYZED. ONCE THE PRODUCT IS RETURNED THE DEVICE WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO NOISE AND A LEAD FRACTURE ISSUE OBSERVED DURING A RECENT DEVICE REPLACEMENT PROCEDURE. DURING THE REPLACEMENT, IT WAS OBSERVED THAT THE ADHESIVE ON THE HEADER OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SLIGHTLY SEPARATED FROM THE DEVICE. THE ATRIAL LEAD WAS THEN TESTED WITH A PACING SYSTEM ANALYZER (PSA) WHICH REVEALED THAT PACING IMPEDANCES HAVE INCREASED OVER TIME. THE DEVICE WAS EXPLANTED, REPLACED AND RETURNED FOR ANALYSIS WHILE THE LEAD WAS ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310765 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R