BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 2051872 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03382
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 22, 2011
    Report Date
    April 26, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE ATRIAL LEAD HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT, THE LEAD WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE ATRIAL LEAD WAS NOT RETURNED TO BOSTON SCIENTIFIC, THEREFORE, THE CLINICAL OBSERVATIONS COULD NOT BE CONFIRMED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEAD WAS DEACTIVATED, SURGICALLY ABANDONED, AND REPLACED IN (B)(6) 2011. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS ATRIAL LEAD EXHIBITED IMPEDANCES GREATER THAN 3,000 OHMS AND LOSS OF CAPTURE. THE ATRIAL LEAD WAS DEACTIVATED AND A REVISION PROCEDURE WAS TO BE PERFORMED IN THE NEAR FUTURE. UPON REMOVAL, THE LEAD WILL BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R