BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3071817 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05266
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    July 17, 2011
    Report Date
    January 17, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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. PRODUCT EVENT SUMMARY THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. SENSING/OVERSENSING: 34-VENTRICULAR NST<(><<)>=210 MS ON (B)(4) 2010. 91-VF<(><<)>=210 MS AVERAGE V-CYCLE BETWEEN (B)(4) 2010 AND (B)(4) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCES, WHICH RESULTED IN THE LEAD BEING UNABLE TO DELIVER THERAPY DURING AN EPISODE OF VENTRICULAR FIBRILLATION (VF). THE LEAD WILL CONTINUE TO BE MONITORED, AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171483 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Life Threatening 7304 IMPLANTABLE DEFIBRILLATOR