BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIRTUOSO II DR

    MDR report key: 2060284 · Received April 15, 2011

    Report

    Report Number
    2647346-2011-00555
    Event Type
    Death
    Date Received
    April 15, 2011
    Date of Event
    November 16, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S157
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.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

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) AND WAS RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. INFORMATION IDENTIFIED IN THE MANUFACTURE'S DATA BASE INDICATION THE PATIENT DIED APPROXIMATELY EIGHT MONTHS POST THE IMPLANT OF THE ICD. FOLLOW UP INFORMATION REVEALED THAT THE DEVICE WAS LAST INTERROGATED BY THE CLINIC FOUR MONTHS PRIOR TO THE DEATH AND HAD BEEN FUNCTIONING SATISFACTORILY. CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    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 80 YR Death 0184 IMPLANTABLE TACHY LEAD| 4086 IMPLANTABLE PACING LEAD