BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 2812353 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02565
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    January 7, 2013
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY (B)(4) 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.

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. THE SAVE TO DISK NOTED DEVICE ALERT FOR LOW BATTERY VOLTAGE RECOMMENDED REPLACEMENT TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DID NOT MEET THE PERCEIVED LONGEVITY ESTIMATES. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS 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 DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC S.A. D164AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R