BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO II DR

    MDR report key: 4833172 · Received June 10, 2015

    Report

    Report Number
    3004209178-2015-11253
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 14, 2015
    Report Date
    April 14, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Removal / Correction Number
    Z-0117-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: 694958 LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED ENDOCARDITIS. THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377550 VIRTUOSO II DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D274DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R 5076-52 LEAD