BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO II DR

    MDR report key: 2201671 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-03791
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    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
    PA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE VENTRICULAR LEAD DISPLAYED OVERSENSING, NOISE AND VARYING IMPEDANCE. THE SAVE TO DISK DATA INTERPRETATION SUGGESTS A MISALIGNED RING CONNECTION ON THE DEVICE. THE SYSTEM IS STILL IN USE. 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 73 YR Other 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD