BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 6142152 · Received December 2, 2016

    Report

    Report Number
    3008973940-2016-00885
    Event Type
    Death
    Date Received
    December 2, 2016
    Date of Event
    November 24, 2016
    Report Date
    November 30, 2016
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS, HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE TREND ON THE ATRIAL PACING LEAD WAS RISING. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS FOUND UNRESPONSIVE AND EXPIRED AT HOME. THE CAUSE OF DEATH IS NOT KNOWN. IT WAS ALSO REPORTED THE PATIENT HAD NOT BEEN WELL WEEKS PRIOR TO DEATH FROM AN UNIDENTIFIED ¿GUT ISSUE.¿ A REQUEST FOR DEVICE PERFORMANCE ANALYSIS WAS MADE, ANALYSIS WAS PERFORMED, AND THE LEADS WERE FOUND TO TEST OUT OF SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791981 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death DDBC3D4 ICD, 6947M62 LEAD