BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR LEAD ADAPTER

    MDR report key: 1940414 · Received December 20, 2010

    Report

    Report Number
    2183787-2010-00079
    Event Type
    Injury
    Date Received
    December 20, 2010
    Report Date
    December 17, 2010
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    K870562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW AND CONFIRMATION OF MANUFACTURING RECORDS WAS PERFORMED. NO ANOMALIES WERE FOUND. IT CANNOT BE DETERMINED WHETHER THE EVENT WAS RELATED TO DEVICE PERFORMANCE, OR PT CONDITION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS ADAPTER ASSOCIATED WITH THE PATIENT'S DEVICE SYSTEM WAS EXPLANTED, DUE TO POCKET INFECTION. A NEW DEVICE SYSTEM MAY BE IMPLANTED ONCE THE PATIENT IS CLEARED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR LEAD ADAPTER BIPOLAR ADAPTER DTB GREATBATCH MEDICAL 501214 W1228223

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention