BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35 CM BIPOLAR LEAD

    MDR report key: 2193008 · Received July 21, 2011

    Report

    Report Number
    2183787-2011-00063
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Report Date
    July 20, 2011
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    K925099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: REVIEW AND CONFIRMATION OF MANUFACTURING RECORDS WERE PERFORMED. NO ANOMALIES WERE FOUND. CONCLUSION: IT CANNOT BE DETERMINED WHETHER THE EVENT WAS RELATED TO DEVICE PERFORMANCE, OR PT CONDITION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT THE RIGHT VENTRICULAR (RV) LEAD IN THIS PACEMAKER DEPENDENT PT WAS SURGICALLY ABANDONED DUE TO LOSS OF CAPTURE AND AN INCREASED THRESHOLD MEASUREMENT OF 3 VOLTS AT 0.8 MS. A NEW RV LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 35 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511211 M24968

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention