BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4251972 · Received November 14, 2014

    Report

    Report Number
    2649622-2014-13022
    Event Type
    Death
    Date Received
    November 14, 2014
    Date of Event
    September 25, 2014
    Report Date
    December 11, 2014
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. ATTEMPT(S) FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED. VISUAL ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED FROM (B)(6) FUNERAL HOME STATING CAUSE OF DEATH WAS "END OF LIFE". INFORMATION IDENTIFIED IN THE PAPERWORK INDICATED THE PATIENT DIED APPROXIMATELY 5 MONTHS POST IMPLANT OF THE ICD SYSTEM. ADDITIONAL INFORMATION REGARDING THE DEATH OF THE PATIENT WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737451 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M55

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Death DTBA1D4 ICD, 429688 LEAD, 407645 LEAD