BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    54 CM STEROID ELUTING BIPOLAR LEAD

    MDR report key: 4060294 · Received August 8, 2014

    Report

    Report Number
    2183787-2014-00094
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 27, 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 HAD BAD STIMULATION THRESHOLD. A NEW LEAD WAS IMPLANTED. THE OLD LEAD WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472998 54 CM STEROID ELUTING BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 1084T-54 W2543639

    Patients

    Seq Age Sex Outcome Treatment
    1