BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYOPORE SUTURELESS MYOCARDIAL PACING LEAD 54CM

    MDR report key: 4301208 · Received December 2, 2014

    Report

    Report Number
    2183787-2014-00150
    Event Type
    Death
    Date Received
    December 2, 2014
    Date of Event
    June 4, 2013
    Report Date
    November 25, 2014
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    P130012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A REGISTRATION FORM WAS RECEIVED STATING THAT THIS PATIENT HAD DIED. NO FURTHER INFORMATION WAS PROVIDED. ATTEMPTS TO OBTAIN MORE INFORMATION WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777165 MYOPORE SUTURELESS MYOCARDIAL PACING LEAD 54CM BIPOLAR EPICARDIAL LEAD DTB GREATBATCH MEDICAL 511212 W1250506

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Death