BEUDAMED
    FDA Adverse Event Injury Summary report: N

    35 CM BIPOLAR LEAD

    MDR report key: 3850579 · Received May 22, 2014

    Report

    Report Number
    2183787-2014-00072
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    September 30, 2013
    Report Date
    April 25, 2014
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    P130012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THIS LV LEAD WAS REMOVED DUE TO DEVICE EROSION OR INFECTION. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS WAS LISTED AS PERSISTENT (B)(6) BACTEREMIA, PRESUMED CRT-D INFECTION. PATIENT DESCRIPTION: NYHA FC III AND IV ISCHEMIC PATIENT WITH LVEF < = 35% IF QRS IS > = 120 MS, 40 DAYS AFTER MI AND 3 MONTHS AFTER CORONARY INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306523 35 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511211 M23008

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention