BEUDAMED
    FDA Adverse Event Injury Summary report: N

    54CM BIPOLAR LEAD

    MDR report key: 2180874 · Received July 19, 2011

    Report

    Report Number
    2183787-2011-00056
    Event Type
    Injury
    Date Received
    July 19, 2011
    Report Date
    July 19, 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

    REVIEW OF MANUFACTURING RECORDS WAS PERFORMED. RESULTS: REVIEW AND CONFIRMATION OF MANUFACTURING RECORDS WAS PERFORMED. NO ANOMALIES WERE FOUND. CONCLUSION: DEVICE IS PART OF SEVERAL IMPLANTED COMPONENTS THAT COMPRISE A PACING SYSTEM. WE ARE UNABLE TO DETERMINE IF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LABORATORY IN (B)(6) 2011 FOR A SCHEDULED DEVICE REPLACEMENT PROCEDURE. THE PATIENT WAS PRESENTED BACK TO THE EP LABORATORY IN (B)(6) 2011 FOR DEVICE AND LEAD SYSTEM EXTRACTION DUE TO A PATIENT INFECTION. A TEMPORARY PACING LEAD WAS INSERTED AND THE PATIENT WAS SCHEDULED FOR DEVICE/LEAD IMPLANT IN THE NEAR FUTURE. FOLLOWING THE PROCEDURE, THE PATIENT'S HEALTH STATUS DETERIORATED AND THE PATIENT DIED. THE CAUSE OF DEATH WAS ATTRIBUTED TO INFECTION AND OTHER CO-MORBIDITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 54CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511212 M22254

    Patients

    Seq Age Sex Outcome Treatment
    1 Death