BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    54 CM BIPOLAR LEAD

    MDR report key: 4004854 · Received July 23, 2014

    Report

    Report Number
    2183787-2014-00090
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    May 12, 2014
    Report Date
    July 10, 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 CAPED. THE REASON FOR THE LEAD BEING CAPPED WAS LISTED AS "OTHER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429936 54 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511212 W58220

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention