BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3402413 · Received October 10, 2013

    Report

    Report Number
    2649622-2013-12763
    Event Type
    Malfunction
    Date Received
    October 10, 2013
    Date of Event
    April 11, 2013
    Report Date
    August 16, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KZ
    Reporter Occupation
    PHYSICIAN

    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. ONE VENTRICULAR FIBRILLATION (VF) EPISODE AND 5 LEAD FAILURE PREDICTOR EPISODES OF LESS THAN 220 MILLISECONDS V-V CYCLE ARE RECORDED ON (B)(6) 2013. 573 V-SIC HAVE OCCURRED SINCE (B)(6) 2013. LIA TRIGGERED ON 14 MAY 2013 DUE TO MEETING THE CONDITIONS FOR NON-SUSTAINED TACHYCARDIA EPISODES AND V-SIC.

    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. PRODUCTS: (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  2013 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DOUBLE VENTRICULAR SENSING OBSERVED ON THE STRIP, AND THE R WAVES ON THE RIGHT VENTRICULAR (RV) LEAD WERE LOW. X-RAYS WERE PERFORMED, AND THE RV LEAD WAS SUSPECTED TO BE DISLODGED. THE RV 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
    521146 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR