BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3993305 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09395
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 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 ACTUAL LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE TREND ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS RISING, AND OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER) WERE DETECTED. THE ANALYST NOTED THE MAX RIGHT VENTRICULAR PACING IMPEDANCE ROSE FROM 632 OHMS THE WEEK ENDING (B)(6) 2014 TO 872 OHMS THE WEEK ENDING (B)(6) 2014. THERE WERE 3 NON-SUSTAINED TACHYCARDIA EVENTS RECORDED BETWEEN (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 DEVICE WAS APPROACHING ELECTIVE REPLACEMENT INDICATOR (ERI) AND EXHIBITED "STRANGE BEHAVIOR"; THEREFORE, THE PHYSICIAN DECIDED TO REPLACE THE DEVICE. IT WAS FURTHER REPORTED THAT EPISODES OF HIGH PACING LEAD IMPEDANCE, NOISE AND NONSUSTAINED VENTRICULAR TACHYCARDIA WERE OBSERVED IN THE RIGHT VENTRICULAR (RV) LEAD. THE PACE/SENSE PORTION OF THE LEAD WAS REPLACED AND THE HIGH VOLTAGE COILS REMAIN 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
    471375 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R D164AWG ICD