BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1951539 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23303
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 DURING A DEVICE INTERROGATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD REACHED END OF LIFE (EOL) OVER EIGHT MONTHS EARLIER. THE VOLTAGE WAS 2.17 WITH CHARGE TIMES OF 32.5 SECONDS. IT WAS ALSO NOTED AT THIS TIME THAT THE ATRIAL TRANSVENOUS LEAD HAD A LOSS OF CAPTURE WITH IMPEDANCES GREATER THAN 2500 OHMS. AS A RESULT THE DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION AND BEING RETURNED FOR ANALYSIS. THE ATRIAL LEAD WAS SURGICALLY ABANDONED AND REPLACED. THE DEVICE WAS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention H170| 4136| N119| 4047| 4086| 4063| 0185| 4479