BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO II DR

    MDR report key: 1923024 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-06032
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 17, 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
    CT, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS HAD INFLAMMATORY ALLERGIES IN THE PAST. AN ALLERGY TEST KIT WAS REQUESTED. THE DEVICE IS STILL 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
    1 VIRTUOSO II DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D274DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE TACHY LEAD