BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2911742 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16753
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 6, 2012
    Report Date
    January 16, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. 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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO DOCUMENTED ASYSTOLE GREATER THAN TWO SECONDS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD WERE 290 OHMS IN BIPOLAR CONFIGURATION AND 360 OHMS IN UNIPOLAR CONFIGURATION. THE DEVICE WAS PROGRAMMED TO UNIPOLAR CONFIGURATION AND THE SENSITIVITY WAS DECREASED DUE TO SOME MYOPOTENTIAL OVERSENSING. SOME NOISE WAS NOTED WHEN MANIPULATING THE DEVICE; HOWEVER, IT WAS NOT CONSISTANT THEREFORE AND ISSUE WITH THE OUTER INSULATION WAS SUSPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18468 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening