BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4830047 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-06314
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    March 17, 2015
    Report Date
    March 17, 2015
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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. 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 THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WAS TRIGGERED ON (B)(6) 2015 DUE TO SENSING INTEGRITY COUNTER GREATER THAN 30 IN 3 DAYS AND 2 OR MORE HIGH RATE NON-SUSTAINED TACHYCARDIA EPISODES. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. BEGINNING ON (B)(6) 2015 THE RV PACING IMPEDANCE SPIKED TO 3268 OHMS. ADDITIONALLY, ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). BEGINNING (B)(6) 2014, VENTRICULAR SENSING INTEGRITY COUNTS WERE UP TO 177 WITH ONE VENTRICULAR TACHYCARDIA NON-SUSTAINED EPISODE WITH EVIDENCE OF LEAD NOISE OVERSENSING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE, HIGH THRESHOLDS, SENSING NOISE, AND CONTAINS AN APPARENT FRACTURE. 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
    374188 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R D364VRM ICD