BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35 CM BIPOLAR LEAD

    MDR report key: 1931915 · Received November 30, 2010

    Report

    Report Number
    2183787-2010-00070
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Report Date
    November 30, 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 AND CONFIRMATION OF MANUFACTURING RECORDS WAS PERFORMED. NO ANOMALIES WERE FOUND. CONCLUSIONS: IT CANNOT BE DETERMINED WHETHER THE EVENT WAS RELATED TO DEVICE PERFORMANCE, OR PATIENT CONDITION.

    Description of Event or Problem · 1

    (B)(6) RECEIVED INFORMATION ABOUT A JOURNAL ARTICLE STUDYING LEAD SURVIVAL BASED ON EPICARDIAL PACEMAKER PLACEMENT. THIS STUDY INVOLVED PRODUCTS FROM SEVERAL DIFFERENT MANUFACTURERS, INCLUDING (B)(6). DURING THE COURSE OF THE STUDY, 43% OF THE PATIENTS EXPERIENCE ONE OR MORE LEAD FAILURES WITHIN 3.7 YEARS AND 28% EXPERIENCED LEAD FAILURES WITHIN 3.1 YEARS. THE MAJORITY OF THE LEADS FAILED DUE TO HIGH THRESHOLDS, LEAD FRACTURES, AND SENSING PROBLEMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED IN THE ARTICLE. NO MODEL AND SERIAL NUMBER INFORMATION WAS PROVIDED IN THE ARTICLE AND ATTEMPTS TO OBTAIN THE INFORMATION WERE CONDUCTED. ADDITIONAL INFORMATION WAS LATER REPORTED THAT THIS EPICARDIAL LEAD HAD FRACTURED. JOURNAL ARTICLE REFERENCE: LICHTENSTEIN BJ, ET AL. SURGICAL APPROACHES TO EPICARDIAL PACEMAKER PLACEMENT: DOES POCKET LOCATION AFFECT LEAD SURVIVAL? PEDIATRIC CARDIOLOGY. 2010 AUG 6: EPUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 35 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511211 M24724

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention