BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 2791470 · Received October 15, 2012

    Report

    Report Number
    6000094-2012-02208
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. EVALUATION SUMMARY: (B)(4): WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. TIME OF RRT (RECOMMENDED REPLACEMENT TIME) IN SAVE TO DISK ON (B)(4) 2012 DEVICE RRT <=2.62 VOLT. WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN BAT=2.64 TO 2.62 VOLTS BETWEEN (B)(4) 2012. TWO - PATIENT ALERTS FOR LOW BATTERY VOLTAGE ON (B)(4) 2012 02:15:03 AND (B)(4) 2012 02:15:03. 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

    IT WAS REPORTED THAT THE DEVICE REACHED PREMATURE BATTERY DEPLETION AND THERE WAS A QUESTION AS TO WHETHER THIS NORMAL LONGEVITY BEHAVIOR. THEREFORE, THE DEVICE WAS REMOVED AND REPLACED WITH A NEW DEVICE. 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 S.A. D164AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R 0181 COMPETITOR IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD