BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3071667 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05252
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY TDK092034V: 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 IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE; ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER), THERE WERE TWO - PATIENT ALERTS FOR OUT OF TOLERANCE (OOT) SUB-THRESHOLD LEAD IMPEDANCE ON (B)(6) 2013. DAILY PACE LEAD TREND DATA SHOWS AN ABRUPT INCREASE FOR VENTRICULAR PACE BI IMPEDANCE = 608 TO 4047 OHMS PEAK BETWEEN (B)(6) 2013. VENTRICULAR SHORT INTERVAL COUNT V-SIC=1288 COUNTS, IN 1.61 DAYS, BETWEEN (B)(6) 2013.

    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: D364DRM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD),  IMPLANTED: (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN TWO DAYS POST IMPLANT, THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR IMPEDANCE GREATER THAN 3000 OHMS. INTERROGATION ALSO SHOWED THE RV LEAD OVERSENSING NOISE DURING ATRIAL PACING AND THERE WAS INCREASING VENTRICULAR FIBRILLATION (VF) AND SHORT INTERVAL COUNTS (SIC). IT WAS NOTED THAT THE LEAD PLACEMENT WAS VERIFIED ON X-RAY AND THAT DURING THE LEAD REVISION ON INSPECTION OF THE DEVICE HEADER THE RV LEAD CONNECTOR PIN POSITION WAS CONFIRMED BY THE BLUE MARKER ON THE LEAD. THE RV LEAD WAS DISCONNECTED AND CHECKED THROUGH THE ANALYZER AND ALL MEASUREMENTS WERE AS THEY HAD BEEN AT IMPLANT. THE RV LEAD WAS CONNECTED TO THE DEVICE HEADER AND ELECTRICAL MEASUREMENTS WERE TAKEN AGAIN. THE RV LEAD IS STILL 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
    171434 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| R