BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3860946 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06807
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    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: PRODUCT ID 559453, LEAD, IMPLANTED: (B)(6) 2012; PRODUCT ID 419688, LEAD, IMPLANTED: (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. ANALYSIS OF THE DEVICE MEMORY ALSO INDICATED PACING CAPTURE THRESHOLD IN THE RV (RIGHT VENTRICLE) WAS ELEVATED AND OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). 2014-04-03 RIGHT VENTRICULAR (RV) LEAD INTEGRITY WARNING FOR NON-SUSTAINED TACHYCARDIA EPISODES AND RV LEAD IMPEDANCE VARIATION. BEGINNING (B)(4) 2014, RV LEAD IMPEDANCE SPIKED FROM 700 OHMS TO 1577 OHMS TO A HIGH OF 4047 OHMS. BEGINNING (B)(4) 2014 ABRUPT THRESHOLD INCREASE GREATER THAN 2.5 VOLTS BEGINNING (B)(4) 2014, SIC COUNTS 1738.GEO EVENT DESCRIPTION: IT WAS REPORTED THAT A "PATIENT ALERT" HAD SOUNDED. A HIGH RV IMPEDANCE VALUE WAS OBSERVED (>3000 OHMS).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED TO THE CLINIC AFTER HEARING THE PATIENT ALERT. AN INTERROGATION FOUND THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH IMPEDANCE AND HAD NO CAPTURE. A REVIEW OF THE DEVICE MEMORY INDICATED AN INCREASED SHORT INTERVAL COUNTS (SIC) AND A NUMBER OF FAST NON-SUSTAINED TACHYCARDIA EPISODES. A FRACTURE WAS SUSPECTED. ALL DETECTIONS ON THE LEAD WERE TURNED OFF AND THE LEAD WILL BE REVISED AT THE NEXT DEVICE CHANGE-OUT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342174 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-75

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention D234TRK ICD