BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3153463 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06041
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 OVERSENSING WITH VENTRICULAR NON-SUSTAINED TACHYCARDIA LESS THAN OR EQUAL TO 210 MS ON (B)(6) 2013 AND VENTRICULAR FIBRILLATION LESS THAN OR EQUAL TO 210 MS AVERAGE VENTRICULAR CYCLE BETWEEN (B)(6) 2013. A LEAD INTEGRITY ALERT WAS TRIGGERED ON (B)(6) 2013 FOR LEAD FAILURE PREDICTOR AND OUT OF TOLERANCE LEAD IMPEDANCE ON (B)(6) 2013. HIGH RIGHT VENTRICULAR (RV) PACING LEAD IMPEDANCE WAS NOTED WITH A PATIENT ALERT FOR OUT OF TOLERANCE IMPEDANCE ON (B)(6) 2013. DAILY PACING IMPEDANCE TREND DATA SHOWS A SPIKE INCREASE FOR RV PACING IMPEDANCE EQUAL TO 472 OHMS TO UNSPECIFIED MEASUREMENT BETWEEN (B)(6) 2013. ALSO, THERE WAS NON-PHYSIOLOGIC OVERSENSING/SHORT INTERVAL COUNTS EQUAL TO 3,105 COUNTS IN 0.83 DAY BETWEEN (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO NOISE IN THE RIGHT VENTRICULAR (RV) LEAD. HIGH RV PACING IMPEDANCE AND OVERSENSING WITH A HIGH NUMBER OF SHORT V-V INTERVALS WERE ALSO REPORTED. THE LEAD WAS CAPPED AND REPLACED WITH A NEW LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258818 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694775

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Hospitalization| L| R D144VRC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR