BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYOPORE SUTURELESS MYOCARDIAL PACING LEAD 54CM

    MDR report key: 4992614 · Received August 11, 2015

    Report

    Report Number
    2183787-2015-00087
    Event Type
    Death
    Date Received
    August 11, 2015
    Date of Event
    January 22, 2015
    Report Date
    July 30, 2015
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    UDI-DI
    0082526497704
    PMA / PMN Number
    P130012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE IMPLANTING FACILITY TWO EPICARDIAL LEADS WERE IMPLANTED IN THIS PATIENT. IT WAS NOTED ON THE FORM THAT ONLY THE LEADS WERE IMPLANTED AND NO GENERATOR. FURTHER INFORMATION WAS THEN RECEIVED FROM THE PATIENT'S FAMILY THAT THE PATIENT DID NOT SURVIVE THE SURGERY. THE PATIENT'S DATE OF DEATH WAS NOTED TO BE THE SAME DATE THE LEADS WERE IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. THE LEADS HAVE NOT BEEN RETURNED. THIS IS THE SAME EVENT AS MDR 2183787-2015-00088.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527491 MYOPORE SUTURELESS MYOCARDIAL PACING LEAD 54CM BIPOLAR EPICARDIAL LEAD DTB GREATBATCH MEDICAL 511212 W2778076 0082526497704

    Patients

    Seq Age Sex Outcome Treatment
    1 Death