BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    54 CM BIPOLAR LEAD

    MDR report key: 2021325 · Received February 8, 2011

    Report

    Report Number
    2183787-2011-00015
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Report Date
    February 9, 2011
    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

    EVAL RESULTS: REVIEW AND CONFIRMATION OF MANUFACTURING RECORDS WAS 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 REC'D INFORMATION THAT THE PACER DEPENDENT PT WITH THIS LEFT VENTRICULAR (LV) LEAD WAS HOSPITALIZED AFTER INTERMITTENT LOSS OF CAPTURE (LOC) ON BOTH THE LV AND RIGHT VENTRICULAR (RV) LEAD. THE LV AND RV LEAD ALSO DISPLAYED HIGH PACING THRESHOLDS. A REVISION PROCEDURE WAS PERFORMED DURING WHICH THE LV LEAD WAS TURNED OFF. ATTEMPTS TO PLACE A NEW LV LEAD WERE UNSUCCESSFUL. THERE WERE NO ADDITIONAL ADVERSE PT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 54 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511212 M26928

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention