BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO II DR

    MDR report key: 1924036 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06074
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    September 30, 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
    GA, 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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NOT IMPLANTED DUE TO VARYING IMPEDANCES. A NEW DEVICE WAS IMPLANTED. NO 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 39 YR Other 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD