BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO II VR

    MDR report key: 2203310 · Received August 11, 2011

    Report

    Report Number
    2647346-2011-01031
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 28, 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
    FL, 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 ONE DAY POST IMPLANT THE LEAD'S SENSING VALUE DECREASED. THE LEAD DISLODGED AND THE DEVICE MIGRATED RESULTING IN BOTH BEING REPOSITIONED TWICE DURING THE FIRST FEW DAYS AFTER IMPLANT. IT WAS FURTHER REPORTED THAT THE CAUSE OF THE DISLODGEMENT WAS A DRUG INTERACTION THAT INDUCED BODY MOVEMENT AND AN ALTERED MENTAL STATE. THE DEVICE AND LEAD REMAIN IN USE. THE PATIENT WAS ENROLLED IN THE SYSTEM LONGEVITY STUDY. 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 VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D274VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R