BEUDAMED
    FDA Adverse Event Injury Summary report: N

    54 CM BIPOLAR LEAD

    MDR report key: 1870806 · Received October 11, 2010

    Report

    Report Number
    2183787-2010-00048
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 27, 2010
    Report Date
    October 11, 2010
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    K925099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF MANUFACTURING RECORDS WAS PERFORMED. REVIEW AND CONFIRMATION OF MANUFACTURING RECORDS WAS PERFORMED. THE DEVICE WAS USED OFF-LABEL. THE IFU CLEARLY INDICATES THAT THE USE OF THIS LEAD IS CONTRAINDICATED FOR ATRIAL IMPLANTATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THIS PT HAS FONTAINE DISEASE. THIS ATRIAL LEAD WAS PLACED IN THE PT'S ATRIUM AND THRESHOLD MEASUREMENTS WERE NOTED TO BE 8.0MV, THEREFORE, THE LEAD WAS UNSCREWED FOR REPOSITIONING AND A HOLE WAS OBSERVED IN THE ATRIUM. A FULL STERNOTOMY WAS PERFORMED. NEXT ANOTHER LEAD ((B)(4)) WAS PLACED IN THE ATRIUM AND THE SAME THRESHOLD MEASUREMENT WAS OBTAINED. THEREFORE, THIS LEAD WAS UNSCREWED FROM THE HEART WHICH DID NOT RESULT IN ANOTHER HOLE. THE PHYSICIAN DECIDED TO IMPLANT A COMPETITIVE ENDOCARDIAL LEAD THROUGH THE PREVIOUSLY MADE HOLE. APPROPRIATE THRESHOLD MEASUREMENTS WERE NOTED WITH THIS LEAD. NO OTHER ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 54 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511212 W1327086

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention