BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYODEX STEROID ELUTING BIPOLAR PACING LEAD, 54CM

    MDR report key: 8662610 · Received June 3, 2019

    Report

    Report Number
    2183787-2019-00043
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    May 20, 2019
    Report Date
    May 27, 2019
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE WHOLE CRT SYSTEM WAS EXPLANTED BECAUSE OF INFECTION (ENDOCARDITIS). THE PHYSICIAN DID NOT BELIEVE THE INFECTION WAS RELATED TO ANY OF THE IMPLANTED DEVICES OR ASSOCIATED PROCEDURES. THE GREATBATCH MEDICAL LEAD WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455091 MYODEX STEROID ELUTING BIPOLAR PACING LEAD, 54CM BIPOLAR EPICARDIAL LEAD DTB GREATBATCH MEDICAL 1084T-54 W3683169

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention