BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 5099023 · Received September 23, 2015

    Report

    Report Number
    2649622-2015-10665
    Event Type
    Death
    Date Received
    September 23, 2015
    Date of Event
    August 25, 2015
    Report Date
    October 14, 2015
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL PORTION OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED 11 DAYS FOLLOWING AN UPGRADE PROCEDURE. THE PATIENT WAS REPORTED TO BE BREATHLESS FOR SEVERAL DAYS PRIOR TO DEATH. THE PATIENT HAD A WITNESSED ARREST AND CARDIOPULMONARY RESUSCITATION WAS PERFORMED. A SHOCK WAS WITNESSED FOLLOWED BY BEEPING HEARD FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). DEVICE INTERROGATION WAS PERFORMED AT THE FUNERAL HOME AND IT WAS NOTED THAT THERE WAS FAILURE TO DETECT A VENTRICULAR ARRHYTHMIA. 6 MINUTES AND 22 SECONDS ELAPSED PRIOR TO SHOCK DELIVERY RESULTING IN THE DEATH OF THE PATIENT. THE DEATH WAS CLASSIFIED AS A ARRHYTHMIC DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630095 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Death