BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3191871 · Received June 26, 2013

    Report

    Report Number
    2649622-2013-08142
    Event Type
    Death
    Date Received
    June 26, 2013
    Date of Event
    February 17, 2013
    Report Date
    July 25, 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 WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCTS: D354TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IMPLANTED: (B)(6) 2012; 429688 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2012; 2088TC COMPETITOR IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2012. (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 THE DEVICE CLINIC WITH INFORMATION NOTING THE PATIENT IS DECEASED. NO ADDITIONAL INFORMATION RELATING TO THE PATIENT DEATH WAS PROVIDED. FURTHER REVIEW OF THE MANUFACTURER¿S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY NINE MONTHS AFTER DEVICE SYSTEM IMPLANTED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290416 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 Death