BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3153419 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05994
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED THE RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE WAS OUT OF RANGE HIGH WITH PATIENT ALERTS FOR RV PACE LEAD IMPEDANCE GREATER THAN 2500 OHMS ON (B)(6) 2013. DAILY PACE LEAD TREND DATA SHOWS AN INCREASE FOR RV PACE EQUAL TO 744 TO 2928 OHMS PEAK BETWEEN (B)(6) 2013. THERE WAS ALSO RV OVERSENSING WITH 35 VENTRICULAR NON-SUSTAINED TACHYCARDIA¿S LESS THAN EQUAL TO 210MS BETWEEN (B)(6) 2013. ALSO, 10 VENTRICULAR FIBRILLATIONS LESS THAN EQUAL TO 210MS AVERAGE V-CYCLE BETWEEN (B)(6) 2013. THERE WAS NON-PHYSIOLOGICAL OVERSENSING WITH VENTRICULAR SHORT INTERVAL COUNT EQUAL TO 2244 COUNTS, IN 7.09 DAYS BETWEEN (B)(6) 2013. CONCOMITANT PRODUCT: 4574 IMPLANTABLE PACING LEAD (B)(6) 2010, 4196 IMPLANTABLE PACING LEAD (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS FROM THE RIGHT VENTRICULAR (RV) LEAD DUE TO NOISE ON THE RV CHANNEL. THERE WAS AN APPARENT RV LEAD FRACTURE. THE RV LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256502 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 7279 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR