BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3153389 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05988
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 18, 2013
    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

    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 ID (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (B)(6) 2011. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE PROXIMAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. PRODUCT PERFORMANCE DATA WAS ALSO RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET. ONE PATIENT ALERT FOR LEAD FAILURE PREDICTOR OCCURRED ON (B)(6) 2013. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE TREND ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS VARIABLE. THE DAILY PACE LEAD TREND DATA SHOWS A SPIKE INCREASE FOR VENTRICULAR PACE BIPOLAR IMPEDANCE FROM 855 TO 2299 TO 893 OHMS PEAK BETWEEN (B)(4) 2013. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). VENTRICULAR SIC WAS 1670 COUNTS IN 6.81 DAYS BETWEEN (B)(4) 2013. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING ASSOCIATED WITH THE RIGHT VENTRICULAR LEAD. FOURTEEN NON-SUSTAINED TACHYCARDIA EPISODES <(><<)>=210MS OCCURRED BETWEEN (B)(4) 2013.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HEARD AN ALERT AND CAME TO THE HOSPITAL. THE RIGHT VENTRICULAR LEAD HAD NOISE, OVERSENSING, AND THE IMPEDANCE WAS VARYING. THE DETECTIONS WERE TURNED OFF UNTIL THE LEAD COULD BE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HEARD AN ALERT AND CAME TO THE HOSPITAL. THE RIGHT VENTRICULAR LEAD HAD NOISE, OVERSENSING, AND THE IMPEDANCE WAS VARYING. THE DETECTIONS WERE TURNED OFF UNTIL THE LEAD COULD BE 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
    256381 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-75

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| R