BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTO SECURE

    MDR report key: 2895123 · Received January 3, 2013

    Report

    Report Number
    2649622-2013-00004
    Event Type
    Death
    Date Received
    January 3, 2013
    Date of Event
    August 21, 2010
    Report Date
    February 21, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THROUGH VISUAL SUMMARY THAT THERE WAS APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. INFORMATION IDENTIFIED IN THE MANUFACTURE'S DATA BASE INDICATED THE PATIENT DIED APPROXIMATELY SIX MONTHS POST IMPLANT OF THE ICD SYSTEM APPROXIMATELY TWO YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2484 SPRINT QUATTO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Death (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR