BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO VR

    MDR report key: 2813369 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02500
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. EVALUATION SUMMARY (B)(4) - WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE BATTERY VOLTAGE INDICATED ELECTIVE REPLACEMENT INDICATOR. THE RECOMMENDED REPLACEMENT TIME IN THE SAVE TO DISK ON (B)(6) 2012, INDICATED DEVICE ELECTIVE REPLACEMENT INDICATOR LESS THAN OR EQUAL TO 2.62 VOLTS. THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MINIMUM BATTERY VOLTAGE EQUAL TO 2.64 TO 2.62 VOLTS BETWEEN (B)(6) 2012. THERE WERE TWO PATIENT ALERTS FOR LOW BATTERY VOLTAGE ON (B)(6) 2012. (B)(4) - THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE FOUND A HIGH CURRENT DRAIN CONDITION. ELECTRICAL ANALYSIS FOUND THE CAUSE OF THE HIGH CURRENT DRAIN WAS CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR IN A LITTLE OVER FOUR YEARS. THE DEVICE WAS EXPLANTED AND REPLACED. 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 24 YR Hospitalization| R