BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 3153518 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06069
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    March 18, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    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. PRODUCT EVENT SUMMARY: PERFORMANCE DATA WERE COLLECTED FROM THE DEVICE AND ANALYZED. THE MAXIMUM SUPERIOR VENA CAVA AND ACTIVE CAN IMPEDANCE VALUES VARY BETWEEN AN APPROXIMATE BASELINE OF 60 OHMS TO GREATER THAN 250 OHMS BETWEEN THE WEEKS ENDING (B)(6) 2013. AN OUT OF THRESHOLD SUBTHRESHOLD LEAD IMPEDANCE ALERT WAS RECORDED ON (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED TO HOSPITAL DUE TO HEARING THE PATIENT ALERT ON THE DEVICE. IT WAS OBSERVED THE RIGHT VENTRICULAR LEAD DEFIBRILLATION AND SUPERIOR VENA CAVA IMPEDANCE VALUES WERE HIGH. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257935 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-75

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR D384VRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC