BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 3860658 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05341
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 28, 2014
    Report Date
    February 28, 2019
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD - (B)(6) 2005; 4194 IMPLANTABLE PACING LEAD - (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL LEAD WAS NOT RETURNED; HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCES ON THE SUPERIOR VENA CAVA DEFIBRILLATION COIL AND THE RIGHT VENTRICULAR DEFIBRILLATION COIL, WERE BEYOND THE EXPECTED UPPER RANGE. ADDITIONALLY, THERE WAS A LEAD IMPEDANCE OUT OF RANGE ALERT. THE MAXIMUM SUPERIOR VENA CAVA DEFIBRILLATION IMPEDANCE ROSE FROM AN APPROXIMATE BASELINE OF 50 TO 60 OHMS BETWEEN (B)(4) 2014 AND THE END OF THE RECORD. AN OUT OF THRESHOLD SUB-THRESHOLD LEAD IMPEDANCE ALERT OCCURRED ON (B)(4) 2014.

    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 OF THE SUPERIOR VENA CAVA DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE. ANALYSIS OF THE DEVICE MEMORY INDICATED AN ALERT FOR LEAD IMPEDANCE OUT OF RANGE. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE OF THE RIGHT VENTRICULAR DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE TREND OF THE RIGHT VENTRICULAR DEFIBRILLATION COIL WAS VARIABLE. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE TREND OF THE SUPERIOR VENA CAVA DEFIBRILLATION COIL WAS VARIABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE ON THE HIGH VOLTAGE COIL AND AN APPARENT FRACTURE. 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 FURTHER REPORTED THAT THERE WAS HIGH IMPEDANCE ON THE SVC COIL. THE COIL WAS CAPPED. LATER, A REVISION WAS ATTEMPTED; HOWEVER, THE VEIN WAS OCCLUDED. THE LEAD REMAINS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340447 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR D394TRG IMPLANTABLE DEFIBRILLATOR