BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 6044940 · Received October 20, 2016

    Report

    Report Number
    2649622-2016-13806
    Event Type
    Death
    Date Received
    October 20, 2016
    Date of Event
    October 8, 2016
    Report Date
    December 22, 2016
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX .

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RED ALERT WAS RECEIVED DUE TO RIGHT VENTRICULAR (RV) COIL IMPEDANCE >200 OHMS. THE PATIENT WAS FOUND DEAD AT HOME. THE DATE OF DEATH COULD NOT BE CONFIRMED. IT WAS UNKNOWN IF THE ALERT WAS TRIGGERED POST MORTEM. DEVICE INTERROGATION REVEALED NO THERAPY WAS DELIVERED FROM THE DEVICE. CAUSE OF DEATH IS UNKNOWN. IT WAS UNKNOWN IF THERE WAS AN ALLEGATION FROM THE PHYSICIAN THAT THE DEATH WAS RELATED TO THE RV LEAD HIGH IMPEDANCE. THE PATIENT WAS NOT PACEMAKER DEPENDENT. AN AUTOPSY WILL NOT BE PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695706 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death DTBA2QQ ICD, 4076 LEAD, 4298 LEAD