BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO VR

    MDR report key: 2952123 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01666
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    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) - REVIEW OF PERFORMANCE DATA FOUND NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NOT ABLE TO BE INTERROGATION WIRELESSLY. THE DEVICE WAS ABLE TO HAVE WAND COMMUNICATION FOR INTERROGATION. THE PHYSICIAN ELECTED TO CONTINUE TO USE WANDED TELEMETRY TO INTERROGATE THE DEVICE IN THE FUTURE. THE DEVICE REMAINS 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
    57208 VIRTUOSO VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154VWC

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR 6947 IMPLANTABLE TACHY LEAD