BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 2953793 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-02044
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 12, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    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. (B)(4). CONCOMITANT PRODUCT: (B)(4) IMPLANTABLE TACHY LEAD (B)(6) 2008.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A FAMILY MEMBER THAT SINCE JANUARY THE PATIENT HAS BEEN IN ATRIAL FIBRILLATION (AF). THE PATIENT WAS SHOCKED ANDDEVICE WAS ADJUSTED. IN (B)(6) THE PATIENT WAS SHOCKED WHILE SLEEPING. AFTER HAVING THE DEVICE CHECKED THE PATIENT WAS PUT ON A DIFFERENT MEDICATION. THE 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
    55517 VIRTUOSO DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO D154AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R (B)(4) IMPLANTABLE PACING LEAD