BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO DR

    MDR report key: 2953676 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-02037
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    May 1, 2012
    Report Date
    November 6, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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: 0158 COMPETITOR IMPLANTABLE TACHY LEAD (B)(6) 2003. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SENSING INTEGRITY COUNTER OF THE DEVICE WAS ELEVATED. FOLLOW-UP WAS ATTEMPT TO DETERMINE IF THE OVERSENSING COULD BE ATTRIBUTED TO THE DEVICE OR A COMPETITOR RIGHT VENTRICULAR LEAD, HOWEVER NO ADDITIONAL INFORMATION WAS RECEIVED. THE DEVICE REMAINS 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
    55726 VIRTUOSO DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR 4087 COMPETITOR IMPLANTABLE PACING LEAD