BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO

    MDR report key: 3033427 · Received April 3, 2013

    Report

    Report Number
    2649622-2013-02593
    Event Type
    Death
    Date Received
    April 3, 2013
    Date of Event
    March 2, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 PRODUCTS: (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANTED 2012 (B)(6); 4193 IMPLANTABLE PACING LEAD IMPLANTED 2008 (B)(6); 4076 IMPLANTABLE PACING LEAD IMPLANTED 2008 (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS DECEASED AND DIED APPROXIMATELY SIX MONTHS POST IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) . ADDITIONAL INFORMATION NOTED, THE PATIENT WAS FOUND BY THE PATIENT'S SPOUSE, EMERGENCY SERVICES WERE CALLED AND RESUSCITATION EFFORTS WERE INITIATED. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM WHERE THE PATIENT WAS PRONOUNCED DEAD. IT WAS FURTHER REPORTED THAT A LEAD INTEGRITY ALERT WAS TRIGGERED FOR TWO OR MORE HIGH RATE NON-SUSTAINED EPISODES OF VENTRICULAR TACHYCARDIA AND RIGHT VENTRICULAR LEAD OVERSENSING WAS PRESENT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137261 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Death