BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2040125 · Received April 5, 2011

    Report

    Report Number
    2124215-2011-00657
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    January 5, 2011
    Report Date
    October 16, 2012
    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

    SHOULD FURTHER INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    - -

    Additional Manufacturer Narrative · 1

    THIS IS THE INFORMATION KNOWN AT THIS TIME. WHEN ADDITIONAL INFORMATION HAS BEEN OBTAINED, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR LEAD COLLAPSED AND WAS HOSPITALIZED. INTERROGATION OF THE DEVICE REVEALED VENTRICULAR TACHYCARDIA EPISODES HAD OCCURRED. DURING THESE EPISODES, NOISE WAS REVEALED RESULTING IN PACING INHIBITION LASTING TEN SECONDS IN DURATION. LEAD IMPEDANCE MEASUREMENTS REMAINED WITHIN NORMAL LIMITS. A DEVICE REPLACEMENT PROCEDURE WILL BE PERFORMED IN THE NEAR FUTURE AS THE DEVICE DISPLAYED LESS THAN ONE-HALF YEAR REMAINING. DURING THIS SAME PROCEDURE, THE LEAD INTEGRITY WILL BE INVESTIGATED. THERE HAD BEEN NO PREVIOUS VENTRICULAR TACHYCARDIA EVENTS RECORDED SINCE THE PACEMAKER IMPLANT.

    Description of Event or Problem · 1

    - -

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. A REVISION PROCEDURE WAS PERFORMED. WHEN THIS LEAD WAS DISCONNECTED FROM THE DEVICE AND TESTED WITH THE PACING SYSTEM ANALYZER, NORMAL MEASUREMENTS WERE OBTAINED. A DECISION WAS MADE TO REPLACE THIS LEAD. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. IN ADDITION, THE DEVICE WAS REPLACED. NO FURTHER ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening