BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3160418 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-07991
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    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 PRODUCTS: D154AWG, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, (B)(6) 2009; 5076, IMPLANTABLE PACING LEAD, (B)(6) 2002. (B)(4).

    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 IMPEDANCE TREND ON THE SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL WAS RISING WITH WEEKLY PACE LEAD TREND DATA SHOWS AN INCREASE FOR MAX SVC DEFIB IMPEDANCE EQUAL TO 69 TO 252 OHMS PEAK BETWEEN (B)(4) 2013. ALSO ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE TREND ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS VARIABLE WITH DAILY PACE LEAD TREND DATA SHOWS A SPIKE INCREASE FOR RV PACE EQUAL TO 504 TO 1904 TO 512 OHMS BETWEEN (B)(4) 2013. THE ANALYSIS OF THE DEVICE MEMORY ALSO INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER) WITH VENTRICULAR SIC EQUAL TO 4170 COUNTS, IN 2.25 DAYS, BETWEEN (B)(4) 2013. THE DEVICE MEMORY ALSO INDICATED OVERSENSING ASSOCIATED WITH THE RIGHT VENTRICULAR LEAD WITH FOUR VENTRICULAR NON-SUSTAINED TACHYCARDIA¿S LESS THAN EQUAL TO 200MS ON (B)(4) 2013 AND TWO VENTRICULAR FIBRILLATION EQUAL TO 190MS AVERAGE V-CYCLE ON (B)(4) 2013.

    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 THE PATIENT RECEIVED TWO INAPPROPRIATE SHOCKS FROM THE RIGHT VENTRICULAR (RV) LEAD DUE TO NOISE AND OVERSENSING. ALSO THE RV LEAD PACE/SENSE IMPEDANCE HAD SPIKED FROM 1800 TO GREATER THAN 4000 OHMS. ALSO THE RV LEAD SUPERIOR VENA CAVA COIL IMPEDANCE HAD STARTED SPIKING FROM 60 TO GREATER THAN 200 OHMS THREE MONTHS PRIOR TO THE RV PACING IMPEDANCE SPIKES. THE RIGHT ATRIAL (RA) LEAD IMPEDANCE ALSO STARTED SPIKING TO GREATER THAN 2500 OHMS FOLLOWING A PATIENT FALL FIVE MONTHS PRIOR. THE RA LEAD ALSO HAD OVERSENSING AND UNDERSENSING WITH P-WAVES AT 0.3 TO 0.9 MILLIVOLTS. THE RV AND RA LEADS WERE BOTH CAPPED AND A NEW RV LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260276 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| L| R