BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3973634 · Received August 1, 2014

    Report

    Report Number
    2649622-2014-07678
    Event Type
    Death
    Date Received
    August 1, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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. ATTEMPT(S) FOR ADDITIONAL INFORMATION FROM THE PHYSICIAN AND FUNERAL HOME WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    A PATIENT WITH AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS REPORTED AS DECEASED BY A FAMILY MEMBER. THE FAMILY MEMBER INQUIRED ABOUT THE ROLE THE DEVICE PLAYED THE DEATH. THE FAMILY ALLEGED THAT THE DEVICE CONTRIBUTED TO THE PATIENT DEATH AND THE DEATH OCCURRED A WEEK PRIOR TO THE CALL. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449815 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Death D274DRG ICD