BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3885342 · Received June 19, 2014

    Report

    Report Number
    2649622-2014-07594
    Event Type
    Death
    Date Received
    June 19, 2014
    Date of Event
    May 21, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CLINICIAN THAT THE PHYSICIAN DID NOT SUSPECT THE DEATH OF THE PATIENT WAS RELATED TO THE DEVICE SYSTEM. PER THE PHYSICIAN, THE DEVICE DELIVERED THERAPY FOR VENTRICULAR FIBRILLATION (VF) AND THE RHYTHM WAS CONVERTED TO NORMAL SINUS RHYTHM PRIOR TO DEATH. THE PHYSICIAN SUSPECTED THAT ONE OF THE PATIENT'S CORONARY ARTERY BYPASS GRAFTS CLOSED AND LED TO A MYOCARDIAL INFARCTION AND SUBSUQUENT DEATH. THERE WERE NO ALLEGATIONS OF A DEVICE MALFUNCTION. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM, THE PATIENT WAS FOUND UNRESPONSIVE IN THEIR HOSPITAL ROOM. CPR WAS PERFORMED BUT THE PATIENT DIED. DEVICE INTERROGATION WAS PERFORMED AND REVEALED THE DEVICE WAS PROGRAMMED AS A SINGLE ZONE DEVICE. THE DEVICE TREATED ONE OF SEVERAL VENTRICULAR FIBRILLATION (VF) EPISODES WHICH WAS SUCCESSFUL. DUE TO THE IRREGULAR CYCLE LENGTH DURING THE ARRHYTHMIA THE RATES DROPPED BELOW THE VF DETECTION ZONE OF 340 MS; THE REMAINING EPISODES WERE DETECTED AS NONSUSTAINED TACHYCARDIA (NST) AND NO FURTHER THERAPY WAS PROVIDED. THE SHOCK IMPEDANCE AND OTHER DEVICE MEASUREMENTS APPEARED WITHIN EXPECTED RANGE. A LEAD INTEGRITY ALERT WAS TRIGGERED DUE TO THE SHORT INTERVAL COUNTS AND NST EPISODES; IT WAS SUSPECTED THAT THIS WAS DUE TO THE ARRHYTHMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361450 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Death (B)(4), (B)(4), (B)(4)