BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 1921221 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05710
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Removal / Correction Number
    Z-0128-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4): A HIGH CURRENT DRAIN CONDITION WAS FOUND DURING DEVICE ANALYSIS. ELECTRICAL ANALYSIS FOUND THE CAUSE OF THE HIGH CURRENT DRAIN TO BE CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS.

    Description of Event or Problem · 1

    THE DEVICE WAS REPLACED DUE TO ERI (ELECTIVE REPLACEMENT INDICATOR). THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154AWG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD