BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 2955597 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02107
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. CONCOMITANT PRODUCT: 0185 COMPETITOR IMPLANTABLE TACHY LEAD (B)(6) 2004. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY REMOTE TRANSMISSION THE PATIENT WENT TO THE EMERGENCY DEPARTMENT AFTER RECEIVING AN INAPPROPRIATE SHOCK. IT WAS FURTHER DETERMINED THE EPISODE OF THE SHOCK PRESENTED WITH 60 CYCLE NOISE. IT WAS NOTED THE PATIENT WAS WEARING AN OPERATIONAL TENS UNIT ON THE POSTERIOR MIDDLE TO LOWER THORACIC REGION. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59034 VIRTUOSO DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Hospitalization| L 4469 COMPETITOR IMPLANTABLE PACING LEAD