BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYOPORE SUTURELESS MYOCARDIAL PACING LEAD 54CM

    MDR report key: 5056797 · Received September 4, 2015

    Report

    Report Number
    2183787-2015-00101
    Event Type
    Death
    Date Received
    September 4, 2015
    Date of Event
    July 19, 2011
    Report Date
    August 19, 2015
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    P130012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BY THE DISTRIBUTOR (B)(6) 2015 FROM A HOSPITAL'S DEVICE TRACKING REPORT FORM THAT THIS PATIENT HAD DIED (B)(6) 2011. THE CAUSE OF DEATH WAS NOT REPORTED. ALTHOUGH NOT CONFIRMED, THE PLACEMENT OF THE EPICARDIAL LEADS MAY HAVE OCCURRED AT THE TIME OF A NON-PRODUCT RELATED SURGICAL PROCEDURE (VALVE REPAIR). THIS IS THE SAME EVENT AS REPORTED IN MDR 2183787-2015-00100.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588833 MYOPORE SUTURELESS MYOCARDIAL PACING LEAD 54CM BIPOLAR EPICARDIAL LEAD DTB GREATBATCH MEDICAL 511212 W1758334

    Patients

    Seq Age Sex Outcome Treatment
    1 Death