BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    54 CM BIPOLAR LEAD

    MDR report key: 3748306 · Received January 24, 2014

    Report

    Report Number
    2183787-2014-00018
    Event Type
    Malfunction
    Date Received
    January 24, 2014
    Date of Event
    October 30, 2013
    Report Date
    January 4, 2014
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    P130012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    N/A.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO REPLACE THE PAER THE LEAD WAS CAPPED. NO REASON STATED. NOTE THAT THERE WAS LEAD MODEL 511212, 2/N (B)(4), IMPLANTED ON THE SAME DAY THAT IS NOTED AS CHRONIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55583 54 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511212 W56253

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention