BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 5424617 · Received February 9, 2016

    Report

    Report Number
    2649622-2016-02460
    Event Type
    Injury
    Date Received
    February 9, 2016
    Date of Event
    December 3, 2015
    Report Date
    December 29, 2015
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. 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 OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/ SHORT INTERVAL COUNTS (SIC), THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT, AND THE IMPEDANCE ON THE RIGHT VENTRICULAR (RV) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. ANALYST COMMENTED, BEGINNING (B)(6) 2015, 86 VENTRICULAR SIC; VENTRICULAR TACHYCARDIA (VT) ¿NON SUSTAINED EPISODES WITH EVIDENCE OF LEAD NOISE OVERSENSING. ON (B)(6) 2015, RV PACING IMPEDANCE SPIKED TO GREATER THAN 3000 OHMS UP FROM A TREND IN THE 400-500 OHM RANGE. RV LEAD INTEGRITY WARNING OCCURRED ON (B)(6) 2015 FOR SIC GREATER THAN OR EQUAL TO 30 IN 3 DAYS AND RV LEAD IMPEDANCE VARIATION IN LAST 60 DAYS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO HOSPITAL DUE TO THE DEVICE WAS RINGING. THE PHYSICIAN DETECTED THAT A RIGHT VENTRICULAR (RV) LEAD INTEGRITY ALERT (LIA) STARTED WITH NOISE EPISODES, THE IMPEDANCE WAS HIGH, AND THE VV INTERVALS WERE VERY SHORT. THE RV LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77711 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R