BEUDAMED
    FDA Adverse Event Injury Summary report: N

    54CM BIPOLAR LEAD

    MDR report key: 2011549 · Received March 7, 2011

    Report

    Report Number
    2183787-2011-00020
    Event Type
    Injury
    Date Received
    March 7, 2011
    Report Date
    March 3, 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 CEM RECEIVED INFO THAT THIS LEFT VENTRICULAR (LV) EPICARDIAL LEAD AS PART OF THE DEVICE SYSTEM WAS SURGICALLY ABANDONED DURING THE SURGICAL INTERVENTION TO ADDRESS THE POCKET INFECTION. INITIALLY THE ONLY KNOWN ISSUE WAS NOISE ON THE RA CHANNEL LEADING TO FOUR INAPPROPRIATE MODE SWITCHES. UPON OFFICE FOLLOW-UP, THE PHYSICIAN DETECTED FLUID IN THE DEVICE POCKET AND DEVICE SYSTEM EXPLANT ENUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 54CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511212 W49599

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention