BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 4240638 · Received November 10, 2014

    Report

    Report Number
    2649622-2014-13008
    Event Type
    Death
    Date Received
    November 10, 2014
    Date of Event
    October 8, 2014
    Report Date
    August 13, 2018
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS NOT REGISTERED IN THE MANUFACTURER¿S DATABASE AND PHYSICIAN INFORMATION IS NOT AVAILABLE. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 407652 LEAD IMPLANTED: (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL PORTION OF THE LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. VISUAL ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A FUNERAL DIRECTOR THAT THE PATIENT WAS DECEASED AND REQUESTED THE DEVICE BE DEACTIVATED PRIOR TO EXPLANT FOR CREMATION. IT WAS UNKNOWN IF THE DEVICE SYSTEM WAS RELATED TO THE DEATH OF THE PATIENT. CAUSE OF DEATH WAS UNKNOWN. THE PATIENT DIED 7 DAYS POST IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND ALMOST 2 YEARS FOLLOWING THE IMPLANT OF THE LEADS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT'S SPOUSE THAT THE PATIENT WAS BEING TRANSFERRED FROM A CONVALESCENT HOME TO THE HOSPITAL AND DIED IN THE AMBULANCE EN ROUTE. THE PATIENT'S SPOUSE ALSO STATED THE DEVICE HAD SHOCKED THE PATIENT MANY TIMES IN THE PAST AND KEPT HIM ALIVE. THE PATIENT'S SPOUSE INQUIRED IF THE DEVICE DELIVERED A SHOCK ON THE DATE OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723836 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Death DDBB1D4 ICD