BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35 CM BIPOLAR LEAD

    MDR report key: 3900382 · Received May 6, 2014

    Report

    Report Number
    2183787-2014-00046
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    January 28, 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 DUE TO CAPTURE ISSUES. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271482 35 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511211 W1363461

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention