BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4182068 · Received October 17, 2014

    Report

    Report Number
    2649622-2014-12957
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 23, 2014
    Report Date
    February 6, 2015
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0475-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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 INDICATED A RIGHT VENTRICULAR LEAD INTEGRITY ALERT. THE LEAD INTEGRITY ALERT TRIGGERED FOR TWO OR MORE VENTRICULAR TACHYCARDIA- NON SUSTAINED EPISODES AND INCREASED SIC COUNT.

    Additional Manufacturer Narrative · 1

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

    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. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINED THAT THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED TO THE HOSPITAL DUE TO A PATIENT ALERT. DEVICE INTERROGATION WAS PERFORMED AND A LEAD INTEGRITY ALERT WAS OBSERVED. TECHNICAL REVIEW OF DEVICE DATA NOTED AN INCREASE IN SHORT INTERVAL COUNTS (SIC), TWO NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES CONTAINING PREMATURE VENTRICULAR CONTRACTIONS RESULTED IN A CHANGE IN MORPHOLOGY AND DOUBLE COUNTING OF THE R WAVES WERE OBSERVED. WEEKLY R WAVE TRENDING REVEALED AN INTERMITTENT DECREASE IN R WAVE AMPLITUDES. 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
    660612 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00016 YR D284VRC ICD