BEUDAMED
    FDA Adverse Event Injury Summary report: N

    35 CM BIPOLAR LEAD

    MDR report key: 1940410 · Received December 20, 2010

    Report

    Report Number
    2183787-2010-00077
    Event Type
    Injury
    Date Received
    December 20, 2010
    Report Date
    December 17, 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 OF MANUFACTURING RECORDS WAS PERFORMED. REVIEW AND CONFIRMATION OF MANUFACTURING RECORDS WAS PERFORMED. NO ANOMALIES WERE FOUND. 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 INFO THAT THIS PRODUCT WAS SURGICALLY ABANDONED, DUE TO PATIENT INFECTION. THERE WAS NO REPORT OF ADVERSE PT EFFECTS DUE TO THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 35 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511211 W1437044

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention