BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3230053 · Received July 16, 2013

    Report

    Report Number
    2649622-2013-08213
    Event Type
    Death
    Date Received
    July 16, 2013
    Date of Event
    May 15, 2013
    Report Date
    July 24, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: D274DRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IMPLANTED: (B)(6) 2011; 4568-45 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2004. (B)(4).

    Additional Manufacturer Narrative · 1

    NO EVAL EXPLAIN CODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS DECEASED. THE PATIENT'S FAMILY/FRIEND RETURNED THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ( ICD) SYSTEM AFTER EXPLANT BY THE MORTUARY TO THE PHYSICIAN'S OFFICE. IT WAS FURTHER REPORTED THAT WHEN ATTEMPTING TO INTERROGATE THE DEVICE, A POWER ON RESET (POR) MESSAGE WAS OBSERVED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328373 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Death