BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    54 CM BIPOLAR LEAD

    MDR report key: 2121898 · Received May 23, 2011

    Report

    Report Number
    2183787-2011-00039
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Report Date
    May 23, 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

    RESULTS: REVIEW AND CONFIRMATION OF MFG 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

    (B)(6) RECEIVED INFO THAT TEN DAYS POST-IMPLANT, THE RIGHT VENTRICULAR LEAD WAS EXHIBITING UNDERSENSING, LOSS OF CAPTURE AND HIGH THRESHOLD MEASUREMENTS. IT WAS NOTED THAT THE PT WAS DIABETIC AND HAD BEGUN DIALYSIS. THE LEAD WAS INITIALLY MONITORED. ADDITIONAL INFO WAS LATER RECEIVED THAT SENSING CONTINUED TO DECREASE AND THRESHOLD MEASUREMENTS CONTINUED TO WORSEN. AS A RESULT, THIS LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 54 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511212 W1355290

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention