BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3192462 · Received June 27, 2013

    Report

    Report Number
    2649622-2013-08145
    Event Type
    Death
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0474-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. PRODUCT EVENT SUMMARY: (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING ASSOCIATED WITH THE RIGHT VENTRICULAR LEAD. ANALYSIS OF THE DEVICE MEMORY INDICATED THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET. CONCOMITANT PRODUCTS: (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANTED: 2010 (B)(6); 419688 IMPLANTABLE PACING LEAD IMPLANTED: 2010 (B)(6); 5076-45 IMPLANTABLE PACING LEAD IMPLANTED: 2007 (B)(6). (B)(4).

    Description of Event or Problem · 1

    A CALL WAS RECEIVED FROM THE CLINICIAN REQUESTING REVIEW OF A REMOTE MONITOR TRANSMISSION. THE TRANSMISSION OCCURRED DUE TO TRIGGERING OF A LEAD INTEGRITY ALERT (LIA). DURING THE CONVERSATIONS IT WAS REPORTED THAT THE PATIENT IS DECEASED. THE TRANSMISSION WAS LATER SUCCESSFULLY ABLE TO BE RETRIEVED AND WAS REVIEWED. TECHNICAL SERVICE REVIEW OF THE TRANSMISSION WITH THE CLINICIAN NOTED THAT THE PATIENT HAD VENTRICULAR FIBRILLATION (VF) AND RECEIVED SIX SHOCKS WITHOUT SUCCESSFULLY TERMINATING THE RHYTHM. THE LIA IS NOTED TO BE DUE TO NONPHYSIOLOGIC SENSING AND ELEVATED SHORT INTERVAL COUNTS (SIC). ADDITIONAL INFORMATION RELATED TO THE CAUSE OF DEATH AND CIRCUMSTANCES OF DEATH HAVE BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293416 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Death