BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3051839 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04931
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 8, 2013
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THE DISTAL CONDUCTOR OF THE LEAD WAS EXTRINSICALLY OVER-ROTATED AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    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. (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED; A LEAD IMPEDANCE OUT OF RANGE ALERT, THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET, A LEAD NOISE ALERT, THE IMPEDANCE ON THE SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE, THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE, OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). FIFTEEN NST, 16 VENTRICULAR FIBRILLATION (VF) AND 5 LEAD FAILURE PREDICTOR EPISODES OF LESS THAN 220 MS V-V CYCLE ARE RECORDED BETWEEN (B)(6) 2013. 7,331 OF 8,439 LIFETIME V-SIC OCCURRED SINCE (B)(6) 2013. THE SVC AND RV DEFIB IMPEDANCES INCREASED TO > 250 OHMS AND RV PACING IMPEDANCE WAS > 4,000 OHMS OR UNDEFINED THE WEEK ENDING (B)(6) 2013. A LEAD INTEGRITY ALERT WAS TRIGGERED ON (B)(6) 2013 DUE TO MEETING THE CONDITIONS FOR NST AND V-SIC. AN OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ALERT WAS RECORDED ON (B)(6) 2013. A LEAD NOISE ALERT OCCURRED ON (B)(6) 2013.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE RIGHT VENTRICULAR LEAD ALERTS FOR SUPERIOR VENA CAVA (SVC) IMPEDANCE, RIGHT VENTRICULAR DEFIB IMPEDANCE, AND A LEAD INTEGRITY ALERT WAS TRIGGERED. FURTHER INFORMATION WAS NOT ABLE TO BE OBTAINED. THE LEAD IS NO LONGER IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149458 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R