BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3862299 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06973
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    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. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER) AND THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET. NINETY SIX LIFETIME V-SIC ARE RECORDED BEGINNING (B)(6) 2014. LIA TRIGGERED ON (B)(6) 2014 DUE TO MEETING THE REQUIREMENTS FOR NST AND V-SIC. THERE ARE 4 LEAD FAILURE PREDICTOR (LFP) EVENTS OF LESS THAN 220 MS V-V CYCLE RECORDED BETWEEN (B)(6) 2014.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (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 REMOTE TRANSMISSION INDICATED A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED FOR HIGH RATE NON-SUSTAINED TACHYCARDIA (NST) AND SHORT INTERVAL COUNTS (SIC). THE RIGHT VENTRICULAR (RV) LEAD BIPOLAR IMPEDANCE IS OUT OF RANGE HIGH. THE NST EVENTS ARE CONSISTENT WITH LEAD NOISE OVERSENSING. THE LEAD WAS NOTED TO BE FRACTURED. THE DEVICE WAS REPROGRAMMED FROM TIP-COIL SENSING AND PACING. THE LEAD REMAINS 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
    338383 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention DDBB1D1 ICD