BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    54 CM UNIPOLAR LEAD

    MDR report key: 3243116 · Received July 18, 2013

    Report

    Report Number
    2183787-2013-00064
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    July 12, 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

    Additional Manufacturer Narrative · 1

    NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXHIBITED < 100 OHMS IMPEDANCE. THE LEAD WAS EXPLANTED BECAUSE OF THE IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336528 54 CM UNIPOLAR LEAD UNIPOLAR LEAD DTB GREATBATCH MEDICAL 1043K UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention