BEUDAMED
    FDA Adverse Event Injury Summary report: N

    54CM BIPOLAR LEAD

    MDR report key: 2101474 · Received May 2, 2011

    Report

    Report Number
    2183787-2011-00031
    Event Type
    Injury
    Date Received
    May 2, 2011
    Report Date
    May 2, 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

    METHOD: REVIEW OF MANUFACTURING RECORDS WAS PERFORMED. RESULTS: REVIEW AND CONFIRMATION OF MANUFACTURING RECORDS WAS PERFORMED. NO ANOMALIES WERE FOUND. CONCLUSIONS: 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 REC'D INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO A PT 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 54CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511212 W1478993

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention