BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    54 CM BIPOLAR LEAD

    MDR report key: 3900418 · Received May 6, 2014

    Report

    Report Number
    2183787-2014-00053
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    January 29, 2014
    Report Date
    April 25, 2014
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    P130012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NA.

    Description of Event or Problem · 1

    A DEVICE REGISTRATION FORM WAS RECEIVED STATING THAT THIS LEAD WAS CAPPED. THE REASON FOR THE LEAD BEING CAPPED IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272024 54 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511212 W58233

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention