BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3863354 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06688
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT, AND INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. ANALYSIS OF THE DEVICE MEMORY ALSO INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). THE ANALYST NOTED: (B)(6) 2014 LEAD INTEGRITY ALERT (LIA) ALERT FOR HIGH RATE NST EVENTS AND SIC COUNTS; ALSO TRIGGERING RV LEAD NOISE WARNING. BEGINNING THE WEEK OF (B)(6) 2014, RV PACING IMPEDANCE SPIKED FROM 456 OHMS TO 2375 OHMS. SENSING INTEGRITY COUNTS (B)(4) BEGINNING (B)(6) 2014.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCES AND NOISE. THE LEAD WAS CAPPED 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
    341438 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R