BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3052794 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04064
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 15, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    NOTAPVD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    - -

    Additional Manufacturer Narrative · 1

    WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS RIGHT VENTRICULAR LEAD WAS SUCCESSFULLY REPOSITIONED, REMAINS IMPLANTED AND IN SERVICE. 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 OF THIS RECENTLY IMPLANTED RIGHT VENTRICULAR LEAD AND PACEMAKER, INTERROGATION REVEALED REMAINING LONGEVITY DISCREPANCY OF THE DEVICE. TECHNICAL SERVICES PERFORMED A REVIEW OF THE REMOTE MONITORING DATA AND DETERMINED THE IMPEDANCE MEASUREMENTS HAD DECREASED TWO HUNDRED OHMS WITHIN FOUR DAYS OF IMPLANT. LEAD DISLODGEMENT WAS SUSPECTED. A REVISION WAS PERFORMED. THIS LEAD WAS SUCCESSFULLY REPOSITIONED AND ACCEPTABLE MEASUREMENTS WERE OBTAINED POST PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. REMOTE MONITORING REVEALED RIGHT VENTRICULAR LEAD NOISE. LEAD DISLODGEMENT IS SUSPECTED. A REVISION PROCEDURE IS INTENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    IN ADDITION, TS REVIEWED REMOTE MONITORING DATA. THIS LEAD DISPLAYED UNDERSENSING AND AMPLITUDE FLUCTUATIONS. AN X-RAY TO CONFIRM THE LEAD POSITION WAS SUGGESTED. TS AGREED THAT THE ELECTRICAL PARAMETERS AND ELECTROGRAM ANALYSIS INDICATE LEAD DISLODGEMENT AND RECOMMENDED LEAD REPLACEMENT RATHER THAN REPOSITIONING IF AN INVASIVE PROCEDURE IS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155654 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R MISMATCH| J173| 4136| 4457