BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1954158 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24052
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 13, 2010
    Report Date
    March 23, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN PROGRAMMED THE ASSOCIATED DEVICE TO VVI MODE IN ORDER TO DEACTIVATE THE ATRIAL PORT. AT THIS TIME, THIS ATRIAL LEAD REMAINS IMPLANTED AND THERE ARE NO PLANS ON PERFORMING A LEAD REVISION. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT SEVERAL YEARS LATER, THIS RA LEAD WAS EXHIBITING PACING IMPEDANCE MEASUREMENTS ABOVE 2,000 OHMS. A CHEST X-RAY WAS PERFORMED AND A FRACTURE WAS CONFIRMED. A REVISION WAS PERFORMED AND THIS RA LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NORMAL PATIENT FOLLOW UP, IT WAS DISCOVERED THAT THIS RIGHT ATRIAL (RA) LEAD HAD FRACTURED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| O| R 4087| 4088| 1291