BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 2122190 · Received June 13, 2011

    Report

    Report Number
    6000144-2011-02131
    Event Type
    Injury
    Date Received
    June 13, 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
    TX, 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. EVALUATION SUMMARY (B)(4): THE DEVICE WAS RETURNED AND PER ANALYSIS FINDINGS 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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS REPLACED DUE TO BATTERY DEPLETION. 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 73 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD