BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3122337 · Received May 21, 2013

    Report

    Report Number
    2649622-2013-05420
    Event Type
    Death
    Date Received
    May 21, 2013
    Date of Event
    April 26, 2013
    Report Date
    September 3, 2020
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. (B)(4). CONCOMITANT PRODUCT: D314VRM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IMPLANTED:(B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS DECEASED AND DIED APPROXIMATELY FOUR MONTHS POST IMPLANT. IT WAS FURTHER REPORTED A LEAD INTEGRITY ALERT WAS TRIGGERED FOR NON-SUSTAINED TACHYCARDIA AND OVERSENSING. A MESSAGE WAS LEFT AT THE PATIENT¿S HOME AND A RETURN CALL WAS RECEIVED FROM THE PATIENT¿S DAUGHTER INDICATING THE PATIENT IS DECEASED. ACCORDING TO THE DAUGHTER, THE PARAMEDICS ATTEMPTED TO CARDIOVERT THE PATIENT THREE TIMES WITH NO SUCCESS. THE DEVICE NURSE REPORTED NO SUSPICION OF DEVICE FUNCTION RELATED TO PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223649 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M55

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Death| R