BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYOPORE SUTURELESS MYOCARDIAL PACING LEAD 35CM

    MDR report key: 4222433 · Received October 29, 2014

    Report

    Report Number
    2183787-2014-00128
    Event Type
    Death
    Date Received
    October 29, 2014
    Date of Event
    January 4, 2014
    Report Date
    October 13, 2014
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    P130012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INFO WAS RECEIVED THAT A FAMILY MEMBER CONTACTED TECH SERVICES (TS). THE FAMILY MEMBER HAD RECEIVED A PT VERIFICATION FORM AND WANTED TO KNOW WHY THE SURGEON WOULD HAVE ONLY IMPLANTED THIS EPICARDIAL LEAD. TS WAS NOTIFIED THAT THE PT HAD UNDERGONE HEART VALVE REPLACEMENT IN (B)(6) 2013. THE FAMILY MEMBER COMMENTED THAT THE PT HAD BEEN ADMITTED IN THE HOSPITAL FOLLOWING THE SURGICAL PROCEDURE AND NOTICED THAT THE LEAD BODY APPEARED TO HAVE MIGRATED, BUT HAD NOT ERODED THOUGHT SKIN. TS WAS INFORMED THAT THE PT DIED (B)(6) 2014 AND THE FAMILY MEMBER EXPRESSED DISSATISFACTION WITH THE QUALITY OF MEDICAL CARE THAT THE PT RECEIVED. THE CAUSE OF DEATH WAS REPORTED AS "SYSTEMIC INFECTION OF SOME TYPE". THE FAMILY ASKED THAT THE MEDICAL RECORDS BE UPDATED TO REFLECT THE CHANGE IN THE PT'S STATUS. TS EXPLAINED THAT DURING OPEN HEART SURGERY, IT WOULD NOT BE UNCOMMON FOR THE PHYSICIAN TO PLACE AN EPICARDIAL LEAD IN THE EVENT THE PT COULD BENEFIT FROM CRT PACING IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693395 MYOPORE SUTURELESS MYOCARDIAL PACING LEAD 35CM BIPOLAR EPICARDIAL LEAD DTB GREATBATCH MEDICAL 511211 W2053172

    Patients

    Seq Age Sex Outcome Treatment
    1 Death