BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3053312 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04477
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 15, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WAS SURGICALLY ABANDONED AND WILL NOT BE RETURNED FOR ANALYSIS. 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 DURING A FOLLOW UP VISIT, THIS RIGHT VENTRICULAR LEAD DISPLAYED NOISE. ISOMETRIC MANEUVERS COULD NOT REPRODUCE THE OBSERVATION, HOWEVER WAS NOTED WHEN THE PATIENT WITH THIS LEAD WAS TALKING. ALL OTHER MEASUREMENTS WERE NORMAL AND STABLE. A REVIEW OF THE MEMORY LOGBOOK REVEALED NUMEROUS STORED TACHYCARDIA EPISODES. NO ASYSTOLE GREATER THAN TWO SECONDS WAS OBSERVED. A MEMORY DOWNLOAD WAS PROVIDED TO AN INTERNAL TECHNICAL SERVICE CONSULTANT FOR THEIR REVIEW. DURING A REVIEW OF THE INFORMATION, LOW OUT OF RANGE IMPEDANCE MEASUREMENTS WERE NOTED. IT WAS THOUGHT THERE MAY BE INSULATION DAMAGE DUE TO CLAVICULAR CRUSH OR A TIGHT SUTURE SLEEVE. A REVISION PROCEDURE IS INTENDED. THE PATIENT WAS HOSPITALIZED UNTIL THE REVISION PROCEDURE IS PERFORMED. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. IN ADDITION, AS THE DEVICE WAS REACHING END OF LIFE FOR NORMAL BATTERY DEPLETION, THE DEVICE WAS ALSO REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154814 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4097| 4096| S502