BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3863148 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06561
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - THERE WERE 13 NON-SUSTAINED TACHYCARDIA EPISODES WITH VENTRICLE TO VENTRICLE INTERVALS LESS THAN 220 MILLISECONDS ON (B)(6) 2014. VENTRICULAR SHORT INTERVAL COUNTS (SIC) IS 468 SINCE LAST SESSION 25 DAYS AGO. LEAD FAILURE PREDICTOR TRIGGERED ON (B)(6) 2014. THE RIGHT VENTRICULAR PACE IMPEDANCE WAS GREATER THAN 3000 OHMS STARTING WEEK OF (B)(6)2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EPISODES OF NOISE WERE RECORDED ON THE LEAD. THE LEAD ALSO HAD HIGH IMPEDANCE ON THE PACE/SENSE CONDUCTOR. 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
    340002 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R