BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3162365 · Received June 11, 2013

    Report

    Report Number
    2649622-2013-08063
    Event Type
    Death
    Date Received
    June 11, 2013
    Date of Event
    May 6, 2013
    Report Date
    June 19, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 INDICATED APPARENT EXPLANT DAMAGE. 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. THE DEVICES ASSOCIATED WITH THIS ADVERSE OUTCOME WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO ADDITIONAL INFORMATION. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. (B)(4). IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANTED: (B)(6) 2013; (B)(4) ANNULOPLASTY BAND IMPLANTED (B)(6) 2012; 1156T COMPETITOR IMPLANTABLE PACING LEAD IMPLANTED (B)(6) 2009; 1699TC COMPETITOR IMPLANTABLE PACING LEAD IMPLANTED (B)(6) 2009. (B)(4).

    Additional Manufacturer Narrative · 1

    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 TO THE MANUFACTURER FROM AN UNKNOWN SOURCE WITH INFORMATION INDICATING THE PATIENT IS DECEASED. NO ADDITIONAL INFORMATION WAS PROVIDED. FURTHER REVIEW OF THE MANUFACTURER¿S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY TWO MONTHS AFTER ICD REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262859 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Death