BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3210852 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07430
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 25, 2013
    Report Date
    June 17, 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 PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY A THOROUGH PRODUCT ANALYSIS WAS PERFORMED. THE LEAD¿S CATHODE CONDUCTOR COIL WAS FRACTURED APPROXIMATELY 248 MM FROM THE TERMINAL PIN NEAR THE DISTAL END OF THE SUTURE SLEEVE TIE DOWN SITE. DUE TO THE LOCATION OF THE FRACTURE, THIS WAS CONSISTENT WITH A FATIGUE FRACTURE NEAR THE SUTURE SLEEVE AREA.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS AND HIGH THRESHOLD MEASUREMENTS. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311673 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R 4096| P107| 4592| 4555| 0185