BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4123688 · Received September 26, 2014

    Report

    Report Number
    2649622-2014-10388
    Event Type
    Death
    Date Received
    September 26, 2014
    Date of Event
    August 30, 2014
    Report Date
    August 30, 2014
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 4524-53 LEAD, IMPLANTED: (B)(6) 1998. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED TO THE EMERGENCY ROOM IN FULL ARREST WHERE THE PATIENT EXPIRED. A DEVICE INTERROGATION WAS COMPLETED AND A TECHNICAL REVIEW WAS REQUESTED BY THE PHYSICIAN. TECHNICAL SERVICE SUPPORT REVIEW INDICATED THE BATTERY WAS IN GOOD WORKING ORDER AND THE SENSING AND IMPEDANCES WERE WITHIN EXPECTED RANGE. THE AUTO CAPTURE THRESHOLDS WERE WITHIN THE SAFETY MARGIN. IT WAS NOTED THAT THERE WAS INABILITY TO VERIFY CAPTURE, NOISE WAS OBSERVED, VENTRICULAR UNDERSENSING WAS OBSERVED AND A LEAD INTEGRITY ALERT WAS TRIGGERED. THE PATIENT HAD EIGHT VENTRICULAR FIBRILLATION EPISODES AND HIGH VOLTAGE THERAPY WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602864 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Death D314TRM ICD, 4296-88 LEAD