BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3990499 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08621
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED HIGH IMPEDANCE; THE MAXIMUM VENTRICULAR PACING IMPEDANCE ROSE FROM 456 OHMS THE WEEK ENDING (B)(6) 2014 TO GREATER THAN 1200 OHMS THE WEEK ENDING (B)(6) 2014. OVERSENSING WAS ALSO NOTED AS THERE WERE EPISODES WITH V-V CYCLE LENGTHS OF LESS THAN 220 MILLISECONDS RECORDED BETWEEN (B)(6) 2014 AND (B)(6) 2014. TWELVE THOUSAND ONE HUNDRED AND ONE (12101) OF THE 13129 LIFETIME VENTRICULAR SHORT INTERVAL COUNTS (V-SIC) WERE RECORDED BEGINNING (B)(6) 2014. FINALLY LEAD INTEGRITY ALERTS WERE TRIGGERED ON (B)(6) 2014 DUE TO THE REQUIREMENTS BEING MET FOR NON-SUSTAINED TACHYCARDIA AND V-SIC AND ALSO TWO LEAD NOISE ALERTS WERE TRIGGERED 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

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS FRACTURED. ABOUT THREE MONTHS EARLIER, NOISE COMPATIBLE WITH A LEAD FRACTURE WAS NOTED ON INTERROGATION, BUT THE NOISE COULD NOT BE REPRODUCED IN THE OFFICE. THE PATIENT RETURNED FOR AN INTERROGATION AND NOISE WAS NOTED AGAIN AND THIS TIME IT WAS REPRODUCIBLE. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472762 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| R