BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3232694 · Received July 18, 2013

    Report

    Report Number
    2124215-2013-11274
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 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

    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 OUT OF RANGE LEAD MEASUREMENTS AND LEAD FRACTURE ON THIS RIGHT ATRIAL (RA) LEAD WERE NOTED DURING A ROUTINE FOLLOW UP. THIS LEAD WAS NOT SUCCESSFULLY EXPLANTED DURING NORMAL DEVICE CHANGE OUT, INSTEAD IT WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED THAT THERE WAS NO ADDITIONAL INFORMATION BY PHYSICIAN DURING IMPLANT OF THE DEVICE, ONLY HIGH PACING IMPEDANCE OF MORE THAN 3000 OHMS AND NOISE IN THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333130 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R