BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR LEAD ADAPTER

    MDR report key: 1881742 · Received October 11, 2010

    Report

    Report Number
    2183787-2010-00049
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 19, 2010
    Report Date
    October 11, 2010
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTD
    PMA / PMN Number
    K870562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS EXTENDER IN ASSOCIATION WITH TRANSVENOUS RIGHT ATRIAL (RA) LEAD WAS DETERMINED TO BE FRACTURED. IN AN ATTEMPT TO REMOVE THE FRACTURED EXTENDER, THE RA LEAD BECAME DISLODGED. BOTH OF THESE WERE REMOVED FROM SERVICE. THERE WERE NO REPORTED ADVERSE PATIENT SYMPTOMS, BEYOND THE SURGICAL INTERVENTION TO ADDRESS THE FRACTURED EXTENDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR LEAD ADAPTER BIPOLAR ADAPTER DTD GREATBATCH MEDICAL 501214 W1182580

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention