BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3728516 · Received April 7, 2014

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    Report

    Report Number
    2649622-2014-02349
    Event Type
    Death
    Date Received
    April 7, 2014
    Date of Event
    March 5, 2014
    Report Date
    May 20, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE WITH THE FUNERAL HOME AND THE CARDIOLOGIST AND WERE UNSUCCESSFUL. CONCOMITANT PRODUCTS: D334TRG ICD IMPLANTED: (B)(6) 2013; 419478 LEAD IMPLANTED: (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A FUNERAL HOME WITH LIMITED INFORMATION. FURTHER REVIEW OF THE MANUFACTURER¿S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY FIVE MONTHS AFTER DEVICE REPLACEMENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207013 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Death 4076-45 LEAD