BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO II VR

    MDR report key: 3993385 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14634
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 11, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN FELT THAT THE DEVICE MISCLASSIFIED AN EPISODE AS VENTRICULAR TACHYCARDIA, BUT THE CLINICIAN THOUGHT IS WAS A SUPRAVENTRICULAR TACHYCARDIA. THE RIGHT VENTRICULAR COIL TO CAN ELECTROGRAM SHOWED A LOT OF NOISE. BOTH THE DEVICE AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470868 VIRTUOSO II VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D274VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR 6947-65 LEAD