BEUDAMED
    FDA Adverse Event Injury Summary report: N

    35CM BIPOLAR LEAD

    MDR report key: 2011534 · Received March 7, 2011

    Report

    Report Number
    2183787-2011-00024
    Event Type
    Injury
    Date Received
    March 7, 2011
    Report Date
    March 4, 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. 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 PART OF A SYSTEM EXPLANT DUE TO POCKET EROSION. 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 35CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511211 W34549

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention