BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2951705 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00163
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 5, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED. THE WEEKLY PACING LEAD TREND DATA SHOWED AN INCREASE OF MINIMUM AND MAXIMUM RIGHT VENTRICULAR (RV) LEAD PACING FROM 808 TO 3568 OHMS PEAK BETWEEN (B)(6) 2012. THERE WAS A PATIENT ALERT FOR OUT OF TOLERANCE SUB THRESHOLD LEAD IMPEDANCE ON (B)(6) 2012. (B)(4).

    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 LEAD WAS NOT RETURNED FOR ANALYSIS; HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED. THE WEEKLY PACING LEAD TREND DATA SHOWED AN INCREASE OF MINIMUM AND MAXIMUM RIGHT VENTRICULAR (RV) LEAD PACING FROM 808 TO 3568 OHMS PEAK BETWEEN (B)(6) 2012. THERE WAS A PATIENT ALERT FOR OUT OF TOLERANCE SUB THRESHOLD LEAD IMPEDANCE ON (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VIRTUOSO IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MEASURED INCREASING LEAD IMPEDANCE VALUES. THE NOMINAL LEAD IMPEDANCE OF 600 OHM INCREASED TO 1400 OHM AND AFTER THE PATIENT ALERT WAS TRIGGERED A LEAD IMPEDANCE OF 2050 OHM WAS OBSERVED DURING INTERROGATION. US FDA EVENET DESCRIPTION: IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD INCREASING AND HIGH IMPEDANCE, SUSPECTED FRACTURE AND CALCIFICATION. THE RV LEAD WAS EXPLANTED 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
    55695 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Hospitalization| R D164VWC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC