BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO VR

    MDR report key: 1792434 · Received August 11, 2010

    Report

    Report Number
    6000144-2010-03255
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    April 28, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 THE DEVICE AND RV LEAD WERE EXPLANTED. NO FURTHER INFORMATION WAS YIELDED THROUGH FOLLOW UP EMAILS AND CALLS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154VWC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention