BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35 CM UNIPOLAR LEAD

    MDR report key: 3181652 · Received June 14, 2013

    Report

    Report Number
    2183787-2013-00047
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    June 13, 2013
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    K896443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED LOSS OF CAPTURE. THE LEAD IMPEDANCE WAS 15- OHM. THE LEAD REMAINED IMPLANTED AT THE TIME OF INITIAL REPORT BUT INFO WAS LATER REC'D THAT THE LEAD HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271927 35 CM UNIPOLAR LEAD UNIPOLAR LEAD DTB GREATBATCH MEDICAL 1043K

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention