BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 3153352 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05958
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NOISE ON THE RIGHT VENTRICULAR LEAD. IT WAS NOTED THAT ALL TESTING COMPLETED IN DIFFERENT POSITIONS TO TRY TO REPLICATE THE NOISE AND WERE UNABLE TO. THE LEAD REMAINS IN USE AS THE PATIENT WILL BE MONITORED AND A REVIEW IS SCHEDULED IN ONE MONTH'S TIME TO CHECK FOR ANY NOISE RECURRENCE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258098 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1