BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO II VR

    MDR report key: 1874573 · Received October 19, 2010

    Report

    Report Number
    6000144-2010-05386
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    August 30, 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 Location
    NV, US
    Reporter Occupation
    PATIENT

    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. DISCLAIMER: SUBMISSION OF INFORMATION BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING

    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 BY THE PATIENT THAT THEIR IMPLANT SURGERY ON (B)(6) 2010 HAD NOT GONE "CORRECTLY" AND THAT THEY HAD TO GO BACK TO (B)(6) TO HAVE ANOTHER SURGERY. THE DEVICE IS STILL IN USE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU

    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 60 YR Required Intervention 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD