BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    54 CM BIPOLAR LEAD

    MDR report key: 1931901 · Received November 30, 2010

    Report

    Report Number
    2183787-2010-00075
    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

    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 PATIENT CONDITION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS EPICARDIAL LEFT VENTRICULAR (LV) PACING LEAD EXHIBITED LOSS OF CAPTURE AND OUT OF RANGE PACING IMPEDANCE MEASUREMENTS IN ALL PACING CONFIGURATIONS. THE PACING IMPEDANCE MEASUREMENTS WERE GREATER THAN 2,500 OHMS DURING MANUAL TESTING. HOWEVER, THE DAILY MEASUREMENTS STORED IN THE DEVICE SHOW ALL LV PACING IMPEDANCE MEASUREMENTS AS NORMAL. THE LV LEAD WAS TESTED SEVERAL TIMES AND NO GOOD IMPEDANCE MEASUREMENTS WERE OBTAINED. IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED A BAD FALL THAT REQUIRED SURGERY, AND WAS NOW IN A WHEELCHAIR AS A RESULT OF THE FALL. THE RIGHT VENTRICULAR LEAD WAS PROVIDING APPROPRIATE PACING AND HAD NORMAL LEAD MEASUREMENTS. DUE TO THE PATIENT'S CONDITION, NO CHANGES WERE PLANNED FOR THE LV LEAD AT THIS TIME. IT WAS NOT KNOWN WHY THE DAILY MEASUREMENTS WERE NORMAL AND THE MANUAL TESTING WOULD BE OUT OF RANGE. THERE WERE NO ADVERSE PATIENT EFFECTS DUE TO THIS LV LEAD ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention