BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXTEND

    MDR report key: 5848089 · Received August 4, 2016

    Report

    Report Number
    2124215-2016-09885
    Event Type
    Death
    Date Received
    August 4, 2016
    Date of Event
    June 6, 2016
    Report Date
    August 19, 2020
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DTB
    UDI-DI
    00802526397721
    PMA / PMN Number
    P960006/S005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ORIGINALLY SUBMITTED VIA ASR ON REPORT ID # (B)(4) IN Q3/2016 OF THE ASR REPORT SUBMITTED TO THE FDA ON #E2011006, WHICH WAS REVOKED ON 10/02/2017. 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

    MANUFACTURER REPORT CORRESPONDS TO THE INITIAL ASR REPORT SUBMITTED FOR EXEMPTION #E2011006. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION ON (B)(6) 2016 DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED. BOSTON SCIENTIFIC RECEIVED INFORMATION ON (B)(6) 2016 THAT THIS PATIENT HAD DIED ON (B)(6) 2016. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LOCAL REPRESENTATIVE WAS UNABLE TO OBTAIN ADDITIONAL INFORMATION FROM THE PHYSICIAN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501335 FLEXTEND IMPLANTABLE LEAD DTB BOSTON SCIENTIFIC 4086 00802526397721

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Female Life Threatening| H| R| D