BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 4831507 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05523
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    May 5, 2014
    Report Date
    March 11, 2015
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE A SIMILAR 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 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 ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE AND THE IMPEDANCE ON THE SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE. ANALYSIS OF THE DEVICE MEMORY INDICATED PACING CAPTURE THRESHOLD IN THE RV (RIGHT VENTRICLE) WAS ELEVATED AND THERE WAS OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). BEGINNING (B)(6) 2015, 6 V-SICS; NO EPISODES AVAILABLE TO VERIFY LEAD NOISE. DURING THE WEEK OF (B)(6) 2014, SVC COIL IMPEDANCE MEASURED 254 OHMS, UP FROM A TREND IN THE 50-60 OHMS RANGE. DURING THE WEEK OF (B)(6) 2014, RV PACING IMPEDANCE ROSE TO 1216 OHMS UP FROM A TREND IN THE 600-700 OHM RANGE. IMPEDANCES CONTINUED TO RISE TO 3249 OHMS ON (B)(6) 2015. IN (B)6) 2014, RV CAPTURE THRESHOLD ROSE FROM 1.75V TO GREATER THAN 2.5V. CAPTURE THRESHOLD WAS GREATER THAN 2.5V THROUGH (B)(6) 2015. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUPERIOR VENA CAVA (SVC) COIL OF RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR HIGH IMPEDANCE. THE ALERT WAS TURNED OFF. LATER AN ALERT FOR HIGH RV PACING IMPEDANCE WAS TRIGGERED. THE ALERT LEVEL WAS REPROGRAMMED TO INCREASE THE ALERT LEVEL. THE LEAD ALSO HAD AN INCREASE IN THRESHOLD. THE RV ALERT AND RV DEFIBRILLATION ALERTS WERE TURNED OFF AND THE PATIENT WILL BE MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374202 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention D354VRG ICD