BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3051814 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04911
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    April 12, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    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 OVERSENSING ASSOCIATED WITH THE RIGHT VENTRICULAR LEAD. ANALYSIS OF THE DEVICE MEMORY INDICATED THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). FURTHER ANALYSIS COMMENTS REVEALED: THERE WERE 2 - PATIENT ALERTS FOR LEAD FAILURE PREDICTOR ON (B)(6) 2010. SIX - VENTRICULAR NON-SUSTAINED TACHYCARDIAS <(><<)>=210 MS BETWEEN (B)(6) 2010. AND THERE WERE VENTRICULAR SHORT INTERVAL COUNT (V-SIC)=447 COUNTS, IN 15 OF 85 DAYS BETWEEN (B)(6) 2010.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS OVERSENSING AND INAPPROPRIATE DETECTION OF NONSUSTAINED VENTRICULAR TACHYCARDIA OBSERVED IN THE RIGHT VENTRICULAR LEAD. THE LEAD WAS REVISED AND 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
    153186 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R D234TRK IMPLANTABLE CRT-D