BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    54 CM STEROID ELUTING BIPOLAR LEAD

    MDR report key: 4060292 · Received August 8, 2014

    Report

    Report Number
    2183787-2014-00092
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 7, 2014
    Report Date
    July 21, 2014
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THIS LEAD EXPERIENCED HIGH THRESHOLDS. AS A RESULT AN ENDOCARDIAL LV LEAD WAS IMPLANTED (WAS NOT SUCCESSFUL IN THE PAST IN ANOTHER HOSPITAL). IT WAS ASCERTAINED WHAT CAUSED THE HIGH THRESHOLDS. CONDITION OF THIS PATIENT IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473198 54 CM STEROID ELUTING BIPOLAR LEAD BIOPLAR LEAD DTB GREATBATCH MEDICAL 1084T-54 W2132576

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention