BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO II VR

    MDR report key: 1921412 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05762
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 3, 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
    NY, 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.

    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 DEVICE FAILED TO CHARGE OR DELIVER A SHOCK AFTER A 50HZ BURST WAS DELIVERED DURING IMPLANT TESTING. THE REAL-TIME ECG STRIP WAS EXAMINED AND INDICATED THE PRESENCE OF PROGRAMMING, INCLUDING AN ABORT FOLLOWING DETECTION OF THE ARRYTHMIA. THE DEVICE IS STILL IN USE. 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 81 YR Other 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD