BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 4830019 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-06312
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    March 5, 2015
    Report Date
    March 5, 2015
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0474-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    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. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT DETERMINE THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER), THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE AND THE RIGHT VENTRICULAR (RV) LEAD INTEGRITY ALERT WAS TRIGGERED. IT WAS NOTED THAT BEGINNING 2015 (B)(6), THE RV SIC WERE UP TO 42 AND VENTRICULAR TACHYCARDIA NON-SUSTAINED (VT-NS) EPISODES WERE OBSERVED WITH EVIDENCE OF LEAD NOISE OVERSENSING. IT WAS ALSO NOTED ON 2015 (B)(6), THE RV PACING IMPEDANCE SPIKED TO 1463 OHMS UP FROM A TREND IN THE 400-500 OHM RANGE AND THE RV LEAD INTEGRITY WARNING OCCURRED ON 2015 (B)(6) FOR 2 OR MORE HIGH RATE NST EPISODES AND RV LEAD IMPEDANCE VARIATION IN LAST 60 DAYS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE, OVERSENSING WITH NOISE ON THE RV CHANNEL AND A SUSPECTED LEAD FRACTURE. THE LEAD WAS INACTIVATED 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
    377564 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R