BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3223562 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-10076
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 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 THIS RIGHT ATRIAL (RA) LEAD DISLODGED. A HIGH PACING THRESHOLD MEASUREMENT WAS NOTED ON BOTH THE RA LEAD AND THE RIGHT VENTRICULAR (RV) LEAD. IN ADDITION, A LOSS OF CAPTURE WAS NOTED ON THE RA LEAD. A LEAD REVISION WAS SCHEDULED AND WAS THEN SUCCESSFULLY PERFORMED. THE RA LEAD WAS SURGICALLY ABANDONED AND THE RV LEAD WAS REPLACED BY A DIFFERENT LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEADS WERE OUT OF SERVICE AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321990 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R