BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3153443 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06018
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 20, 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
    PO
    Reporter Occupation
    PHYSICIAN

    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. PRODUCT EVALUATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING ASSOCIATED WITH THE RIGHT VENTRICULAR LEAD. THIRTEEN VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES AT <(><<)>=210 MS OCCURRED ON (B)(6) 2013. ANALYSIS OF THE DEVICE MEMORY INDICATED THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET. ONE PATIENT ALERT FOR LEAD FAILURE PREDICTOR OCCURRED ON (B)(6) 2013. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). THE VENTRICULAR SHORT INTERVAL COUNT WAS 107 COUNTS IN 4.04 DAYS BETWEEN (B)(6) 2013. CONCOMITANT PRODUCTS: D294TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT DETERMINE THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALERT WAS TRIGGERED ON THE RIGHT VENTRICULAR LEAD. NON-SUSTAINED TACHYCARDIA EPISODES AND AN INCREASE IN SENSING INTEGRITY COUNTS WAS OBSERVED. WHILE IN OFFICE, NOISE WAS OBSERVED, BUT NOISE COULD NOT BE SOLICITED WITH SHOULDER MANEUVERS. THE DEVICE WAS REPROGRAMMED AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND REPLACED WITH A PREVIOUS LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256678 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R