BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    54CM BIPOLAR LEAD

    MDR report key: 1172284 · Received September 19, 2008

    Report

    Report Number
    2183787-2008-00007
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    June 13, 2008
    Report Date
    August 13, 2008
    Manufacturer
    ENPATH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    K925099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD -- REVIEW AND CONFIRMATION OF MANUFACTURING RECORDS WERE PERFORMED. NO ANOMALIES WERE FOUND. IT CANNOT BE DETERMINED WHETHER THE RISE IN THRESHOLDS WERE RELATED TO DEVICE PERFORMANCE, OR PATIENT CONDITION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (BSC) CRM RECEIVED AND REPORTED THE FOLLOWING INFORMATION: THIS RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED DUE TO SENSING OF 4.9MV, IMPEDANCES OF 354OHMS AND THRESHOLDS AT 2.8V@5MS. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 54CM BIPOLAR LEAD BIPOLAR LEAD DTB ENPATH MEDICAL 511212 W47886

    Patients

    Seq Age Sex Outcome Treatment
    1