BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3160369 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-08023
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    January 1, 2013
    Report Date
    March 20, 2013
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 AN INFECTION WAS NOTED DURING A RIGHT VENTRICULAR LEAD REVISION PROCEDURE FOR A SUDDEN RISE AND HIGH LEAD IMPEDANCE, OVERSENSING, AND LOSS OF CAPTURE. THE DEVICE AND LEAD WERE REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259897 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R D364VRM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR