BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO II DR

    MDR report key: 2143424 · Received June 29, 2011

    Report

    Report Number
    2647346-2011-00923
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    June 24, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S157
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE SYSTEM IMPLANT, THE RIGHT VENTRICULAR LEAD IMPEDANCE WAS HIGHER WHEN MEASURED THROUGH THE ANALYZER THAN WHEN MEASURED THROUGH THE DEVICE. NO PROBLEMS WERE NOTED WITH SENSING AND THRESHOLDS. THE DEVICE AND LEAD REMAIN IN USE AND IMPEDANCE WAS MONITORED POST PROCEDURE AND REMAINED STABLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO II DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D274DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention