BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO VR

    MDR report key: 1992673 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-01025
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 RETURNED AND ANALYZED. PRIMARY RESULTS REVEALED THERE WERE NO ANOMALIES FOUND. THE LEAD IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (B)(6), WITH VEGETATIONS ON THE LEAD. THE DEVICE AND LEAD WERE EXPLANTED. AFTER THE LEAD EXTRACTION, THE PATIENT HAD AN EPISODE OF DESATURATION, WHICH REQUIRED 100% FIO2 AFTER THE LEAD WAS REMOVED, WHICH WAS SUSPECTED TO BE DUE TO DISTAL EMBOLIZATION. THE PATIENT'S BLOOD PRESSURE WAS STABLE THROUGHOUT THE CASE. IT WAS ALSO NOTED THAT THERE WAS PERSISTENT BLEEDING FROM THE EXTRACTION SITE, LIKELY ATTRIBUTED TO ACIDOSIS AND LOW PLATELET COUNT, BUT HEMOSTASIS WAS OBTAINED. 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 VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154VWC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R