BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 4833651 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-07002
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    April 21, 2015
    Report Date
    April 23, 2015
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT: D314TRG ICD, IMPLANTED 2012-(B)(6). (B)(4).

    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 OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). ADDITIONALLY, THE IMPEDANCE ON THE SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE, THE PACING CAPTURE THRESHOLD IN THE RV (RIGHT VENTRICLE) WAS ELEVATED, AND A R-WAVE AMPLITUDE MEASUREMENT ISSUE WAS NOTED. THE ANALYST NOTED THAT BEGINNING (B)(6) 2015, 72 VENTRICULAR SENSING INTEGRITY COUNTS (SIC) WERE SEEN. NO EPISODE WAS PRESENT TO VERIFY LEAD NOISE OVERSENSING AND INAPPROPRIATE SHOCKS. ON (B)(6) 2015, SVC COIL IMPEDANCES MEASURED 101OHMS, AND WERE VARIABLE, UP FROM A TREND IN THE 50-60OHM RANGE. THE RV CAPTURE THRESHOLD HAS CONSISTENTLY PROVIDED MEASUREMENTS GREATER THAN 2.5V FROM (B)(6) 2013 THROUGH (B)(6) 2015. ON (B)(6) 2015, THE R-WAVE AMPLITUDE DECREASED TO 0.5 MILLIVOLTS FOLLOWING A VARIABLE TREND OF AMPLITUDES RANGING FROM 0.375 TO GREATER THAN 20 MILLIVOLTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A ONE TIME OUT OF RANGE (OOR) SUPERIOR VENA CAVA (SVC) IMPEDANCE MEASUREMENT ON THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD. IT WAS ALSO NOTED THAT THERE WAS A HIGH RV THRESHOLD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR SYNCOPE. DEVICE INTERROGATION REVEALED THE RIGHT VENTRICULAR (RV) LEAD DEMONSTRATED INAPPROPRIATE OVERSENSING WITH A POSSIBLE FRACTURE. THE LEAD WAS PARTIALLY EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378573 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| L| R 419488 LEAD, 5076-52 LEAD