BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 3991281 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08174
    Event Type
    Malfunction
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THERE WERE NO ANOMALIES OBSERVED REGARDING THE RETURNED LEAD. ALL ELECTRICAL TESTING WAS WITHIN SPECIFIED PARAMETERS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THERE WAS HIGH THRESHOLD ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS ATTEMPTED AND NOT USED. ANOTHER LEAD WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467962 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1