BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO VR

    MDR report key: 2790664 · Received October 15, 2012

    Report

    Report Number
    6000094-2012-02266
    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
    CH
    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 FOR (B)(4): WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS FOUND BATTERY DEPLETION INDICATED ELECTIVE REPLACEMENT INDICATOR AND TIME OF RECOMMENDED REPLACEMENT TIME (RRT) IN SAVE TO DISK ON (B)(6) 2012 DEVICE RRT LESS THAN EQUAL TO 2.62 VOLT. WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN BAT EQUAL TO 2.64 TO 2.62 VOLTS BETWEEN (B)(6)2012. PATIENT ALERTS FOR LOW BATTERY VOLTAGE ON (B)(6)2012.

    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 FOR (B)(4): WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS FOUND BATTERY DEPLETION INDICATED ELECTIVE REPLACEMENT INDICATOR AND TIME OF RECOMMENDED REPLACEMENT TIME (RRT) IN SAVE TO DISK ON (B)(6) 2012, DEVICE RRT LESS THAN EQUAL TO 2.62 VOLT. WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN BAT EQUAL TO 2.64 TO 2.62 VOLTS BETWEEN (B)(6) 2012. PATIENT ALERTS FOR LOW BATTERY VOLTAGE ON (B)(6) 2012. THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE FOUND A HIGH CURRENT DRAIN CONDITION. ELECTRICAL ANALYSIS REVEALED THE CAUSE OF THE HIGH CURRENT DRAIN WAS CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) WITHIN APPROXIMATELY FOUR YEARS POST IMPLANT AND THE DEVICE LONGEVITY WAS UNEXPECTED. THE DEVICE WAS EXPLANTED AND REPLACED WITH AN UPGRADED 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 VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. D164VWC

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R