BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3990598 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08591
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL LEAD WAS NOT RETURNED; HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THERE WAS OVER-SENSING DUE TO NON-PHYSIOLOGIC SIGNALS PRESENT ON THE SENSING INTEGRITY COUNTER. THERE WERE FIFTY LIFETIME VENTRICULAR SENSING INTEGRITY ENCOUNTERS WHICH WERE RECORDED BEGINNING (B)(6) 2014, AND THERE WAS ONE LEAD FAILURE PREDICTED EVENT OF LESS THAN TWO HUNDRED TWENTY MILLISECONDS IN THE V TO V CYCLE WHICH WAS RECORDED ON (B)(6) 2014.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 6725 ADAPTOR, IMPLANTED: (B)(6) 2014; 5071-53 LEAD, IMPLANTED: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD NOTED A STORED EPISODE OF NOISE AND SHORT INTERVAL COUNTS (SIC). THE OVERSENSING OF NOISE WAS UNABLE TO BE DUPLICATED. THERE WAS NO PLAN OF ACTION AT THIS TIME. 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
    472318 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR DTBA1D1 ICD