BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4133898 · Received October 2, 2014

    Report

    Report Number
    2649622-2014-10400
    Event Type
    Death
    Date Received
    October 2, 2014
    Date of Event
    December 1, 2013
    Report Date
    September 4, 2014
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED APPROXIMATELY 6 MONTHS FOLLOWING THE IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. CAUSE OF DEATH WAS UNKNOWN. THE PATIENT PASSED AWAY WHILE OUT OF TOWN AND RELATIVES REFUSED TO DISCLOSE ANY INFORMATION. NO ADDITIONAL DETAILS ARE KNOWN. THE PATIENT WAS ENROLLED IN THE (B)(6). IT WAS UNKNOWN IF THE DEATH WAS RELATED TO THE ICD SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614429 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR Death DTBA2QQ ICD, 457445 LEAD, 429888 LEAD