BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3942933 · Received July 17, 2014

    Report

    Report Number
    2649622-2014-07654
    Event Type
    Death
    Date Received
    July 17, 2014
    Date of Event
    January 31, 2014
    Report Date
    June 25, 2014
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPT FOR THE CLINIC TO SCHEDULE A PATIENT FOLLOW UP, IT WAS REPORTED BY A FAMILY MEMBER THAT THE PATIENT WAS DECEASED WITH AN UNKNOWN CAUSE OF DEATH. IT WAS REPORTED THAT THE PATIENT DIED DURING THE SLEEP WITHOUT SYMPTOMS AND THERE WAS NO AUTOPSY NOR DEATH CERTIFICATE AVAILABLE. THE PATIENT WAS A PARTICIPANT IN THE (B)(6) STUDY. THE ADVERSE EVENT ADVISORY COMMITTEE (AEAC) ADJUDICATED THIS EVENT AS UNKNOWN DEVICE RELATED AND LEAD RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419443 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M72

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Death DTBC2QQ ICD, 4598 LEAD