BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 6142141 · Received December 2, 2016

    Report

    Report Number
    2649622-2016-13892
    Event Type
    Death
    Date Received
    December 2, 2016
    Date of Event
    November 24, 2016
    Report Date
    November 30, 2016
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 LEAD WAS NOT RETURNED FOR ANALYSIS, HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING ASSOCIATED WITH THE RIGHT VENTRICULAR LEAD. IT ALSO INDICATED THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET, THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE, THE IMPEDANCE ON THE SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE, THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE, THERE WAS OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER),AND THE UNEXPECTED DELIVERY OF A VENTRICULAR TACHYARRHYTHMIA THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS FOUND UNRESPONSIVE AND EXPIRED AT HOME. THE CAUSE OF DEATH IS NOT KNOWN. IT WAS ALSO REPORTED THE PATIENT HAD NOT BEEN WELL WEEKS PRIOR TO DEATH FROM AN UNIDENTIFIED ¿GUT ISSUE.¿ A REQUEST FOR DEVICE PERFORMANCE ANALYSIS WAS MADE, ANALYSIS WAS PERFORMED, AND THE LEADS WERE FOUND TO TEST OUT OF SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791498 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death DDBC3D4 ICD, 5076-52 LEAD