BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2040074 · Received April 5, 2011

    Report

    Report Number
    2124215-2011-00389
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    January 4, 2011
    Report Date
    August 15, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADDITIONAL INFORMATION AVAILABLE AND AT THIS TIME, OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, IT WAS REPORTED THAT THE LEAD WAS CAPPED AND SURGICALLY ABANDONED, AND REPLACED WITH ANOTHER MANUFACTURER'S LEAD. THE PATIENT PASSED AWAY 4.5 MONTHS AFTER THE LEAD REPLACEMENT PROCEDURE; THERE WERE NO ALLEGATIONS OR EVIDENCE THAT THE LEAD WAS ASSOCIATED WITH THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THIS IMPLANTABLE LEAD HAD FRACTURED. A LEAD REVISION PROCEDURE IS TO BE PERFORMED WHERE THE LEAD IS TO BE CUT AND CAPPED. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. AS OF TODAY, THE LEAD REMAINS IN SERVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention 0185| 4087| T125