BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYOPORE SUTURELESS MYOCARDIAL PACING LEAD 35CM

    MDR report key: 4308643 · Received December 2, 2014

    Report

    Report Number
    2183787-2014-00148
    Event Type
    Death
    Date Received
    December 2, 2014
    Date of Event
    September 25, 2014
    Report Date
    October 12, 2015
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    P130012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION AND EROSION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT WAS SURGICALLY ABANDONED.

    Description of Event or Problem · 1

    IT WAS NOTED DURING A SEARCH THROUGH THE DISTRIBUTOR'S MEDICAL RECORDS IN SEPTEMBER 2015 THAT THIS PATIENT DIED 20 DAYS FOLLOWING THE SYSTEM REVISION PROCEDURE IN (B)(6) 2014. THERE WAS NO REPORT THAT THE REVISION PROCEDURE OR THE IMPLANT OF A TEMPORARY RV PACING LEAD CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. THIS IS THE SAME EVENT AS MDR 2183787-2015-00117.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776089 MYOPORE SUTURELESS MYOCARDIAL PACING LEAD 35CM BIPOLAR EPICARDIAL LEAD DTB GREATBATCH MEDICAL 511211 W35012

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R