BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3152949 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05754
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    April 26, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ONE PATIENT ALERT FOR LEAD FAILURE PREDICTOR OCCURRED ON (B)(6)-2013. ONE PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED ON (B)(6)-2013. DAILY PACE LEAD TREND DATA SHOWS AN INCREASE FOR VENTRICULAR PACING BIPOLAR IMPEDANCE OF 551 TO 4047 OHMS RANGE BETWEEN (B)(6)-2012 AND (B)(6)-2013. TWO VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES OF 215 MILLISECONDS OCCURRED ON (B)(6)-2013. EIGHT VENTRICULAR FIBRILLATION (VF) EPISODES OF LESS THAN OR EQUAL TO 210 MILLISECONDS AVERAGE VENTRICULAR CYCLE OCCURRED BETWEEN (B)(6)-2013. VENTRICULAR SHORT INTERVAL COUNTS (V-SIC) OF 5276 COUNTS OCCURRED IN 4.15 DAYS BETWEEN (B)(6)-2013. (B)(4).

    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 RIGHT VENTRICULAR (RV) LEAD HAD AN APPARENT FRACTURE. THE LEAD EXPERIENCED HIGH, OUT OF RANGE IMPEDANCE AND OVERSENSING. THE LEAD WAS CAPPED AND REPLACED. THE PATIENT RECEIVED INAPPROPRIATE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258228 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Hospitalization| L| R