BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3862510 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06865
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    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 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. PRODUCTS: D234DRG ICD IMPLANTED: 2009 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

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

    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 ON THE SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL AND THE RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE. ANALYSIS OF THE DEVICE MEMORY ALSO INDICATED A EAD IMPEDANCE OUT OF RANGE ALERT. THE ANALYST NOTED: AN OUT OF TOLERANCE SUB-THRESHOLD LEAD IMPEDANCE ALERT OCCURRED ON 28 APRIL 2014.MAX SVC DEFIBRILLATION AND ACTIVE CAN IMPEDANCES RISE FROM AN APPROXIMATE BASELINE OF 50 OHMS THE WEEK ENDING 21 MARCH 2014 TO > 120 OHM THE WEEK ENDING 28 MARCH 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALERT WAS TRIGGERED DUE TO HIGH SUPERIOR VENA CAVA (SVC) THRESHOLDS ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS FURTHER REPORTED THAT THE RV THRESHOLDS WERE ALSO HIGH. THE PHYSICIAN BELIEVED THAT THE HIGH THRESHOLDS WERE THE RESULT OF A LEAD FAILURE CAUSED BY THE PATIENT'S OCCUPATION. THE SVC PORTION OF THE LEAD WAS PROGRAMMED OFF, AND A LEAD REPLACEMENT WAS PLANNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE RV LEAD WAS SUBSEQUENTLY CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339876 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 00033 YR Required Intervention 5076 LEAD