BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO II DR

    MDR report key: 1861654 · Received October 8, 2010

    Report

    Report Number
    6000144-2010-04765
    Event Type
    Injury
    Date Received
    October 8, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S157
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 THE PATIENT WAS "FEELING TERRIBLE" WHEN VENTRICULAR PACING. THE PATIENT PREVIOUSLY HAD SINGLE CHAMBER DEVICE AND FELT OK. THE VENTRICULAR PACE SEEMS TO BE TRIGGERED BY A PREMATURE VENTRICULAR CONTRACTION (PVC). THE DEVICE WAS RE-PROGRAMMED FROM MVP TO DDD MODE WITH A LONGER AV DELAY. DEVICE REMAINS IN USE. NO FURTHER 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 45 YR Required Intervention 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD