BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3862361 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06949
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 9, 2014
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS OF THE DEVICE MEMORY INDICATED THE CRITERIA FOR THE RIGHT VENTRICLE (RV) LEAD INTEGRITY ALERT (LIA) WERE MET, IMPEDANCE ON THE RV PACING LEAD WAS BEYOND EXPECTED UPPER RANGE, AND OVERSENSING WAS IDENTIFIED DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). A LIA TRIGGERED ON (B)(6) 2014 DUE TO MEETING THE REQUIREMENTS FOR NONSUSTAINED TACHYCARDIA AND VENTRICLE-SIC. AN OUT OF TOLERANCE (OOT) SUBTHRESHOLD LEAD IMPEDANCE ALERT OCCURRED ON (B)(6) 2014. MAXIMUM VENTRICLE PACE IMPEDANCE RISES WERE FROM 703 OHMS THE WEEK ENDING (B)(6) 2014, TO GREATER THAN 3500 OHMS THE WEEK ENDING (B)(6) 2014. THERE WAS 1 NONSUSTAINED VENTRICULAR TACHYCARDIA (NST) AND 5 LEAD FAILURE PREDICTOR (LFP) EVENTS OF LESS THAN 220 MILLISECOND VENTRICLE-VENTRICLE CYCLE RECORDED ON (B)(6) 2014.

    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 MEDICAL PRODUCTS: 5076 LEAD, IMPLANTED: (B)(6) 2012; 4196-88 LEAD, IMPLANTED: (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    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 A LEAD INTEGRITY ALERT OCCURRED DUE TO IMPEDANCE SPIKES GREATER THAN 3000 OHMS ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS FURTHER REPORTED THAT THERE WERE EPISODES OF NONSUSTAINED VENTRICULAR TACHYCARDIA WITH OVERSENSING, AND A POSSIBLE FRACTURE OF THE LEAD. THE RV LEAD WAS 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
    338471 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R D354TRM CRT-D