BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 3990307 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08691
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    May 13, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY -THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE, BEGINNING (B)(4) 2013 THE SUPERIOR VENA CAVA (SVC) DEFIBRILLATION COIL WAS GREATER THAN 200 OHMS.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LEAD WAS EXPLANTED. A LEAD REPLACEMENT IS PLANNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE WAS OBSERVED TO BE GREATER THAN 200 OHMS. FOLLOW-UP RECEIVED INDICATED THAT THERE HAS BEEN NO INTERVENTION DONE YET. THE CASE IS BEING FOLLOWED. THE LEAD REMAINS IN PLACE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464347 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Hospitalization| R D154VRC ICD