BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 2780959 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13310
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 27, 2012
    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

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE DAY POST IMPLANT, THIS RIGHT VENTRICULAR (RV) LEAD REVEALED HIGH PACING THRESHOLDS AND A LOSS OF CAPTURE (LOC) FOR AN UNKNOWN DURATION. AN X-RAY WAS PREFORMED AND SUGGESTED A PERFORATION OCCURED, HOWEVER THIS COULD NOT BE CONFIRMED. A REVISION PROCEDURE WAS PERFORMED AND DURING THE REMOVAL OF THE LEAD SHOWED AN IN-MOTION CURVE SUGGESTING THAT THE RV LEAD COULD HAVE BEEN PLACED IN THE SINUS CORONARIUS. THE LEAD WAS REMOVED AND REPLACED WITH A COMPETITOR LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD WAS DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L