BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3992198 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09984
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED HIGH RIGHT VENTRICULAR (RV) AND SUPERIOR VENA CAVA (SVC) DEFIBRILLATION COIL IMPEDANCES BEGINNING (B)(6) 2014; THE IMPEDANCES WERE ALSO VARIABLE. AN ALERT WAS TRIGGERED FOR THE HIGH RV COIL IMPEDANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DEFIBRILLATION IMPEDANCE - BOTH THE RV AND SUPERIOR VENA CAVA (SVC) - WERE HIGH AND AN ALERT WAS TRIGGERED. THE PHYSICIANS ARE DISCUSSING A POSSIBLE LEAD EXTRACTION AND 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
    470928 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR D154AWG ICD, 5076-45 LEAD