BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1043100 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33545
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 15, 2008
    Report Date
    October 20, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. THE COMPLETE LEAD WAS RETURNED, WITH DRIED BLOOD NOTED IN THE LUMEN OF THE LEAD AND TERMINAL PIN OPENING. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT 3 YEARS AGO, THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO INAPPROPRIATE ATRIAL PACING DUE TO ATRIAL UNDERSENSING, AS WELL AS HIGH IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. RECENTLY, THIS LEAD WAS EXPLANTED DURING AN UNRELATED PROCEDURE AND RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| O| R THE DEVICE (B)(4) WAS IMPLANTED| THE DEVICE 4088/154158 WAS IMPLANTED 22-APR-2003| THE DEVICE (B)(4) WAS IMPLANTED| THE DEVICE 1294/101234 WAS IMPLANTED 22-APR-2003