BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO VR

    MDR report key: 2955379 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02094
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    February 18, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4): PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED THE TIME OF RECOMMENDED REPLACEMENT TIME WAS 2012-(B)(6) AND THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWED A MINIMUM BATTERY VOLTAGE EQUAL TO 2.64 TO 2.62 VOLTS BETWEEN 2012-(B)(6). THERE WERE TWO LOW BATTERY VOLTAGE ALERTS; ONE ON 2012-(B)(6).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD UNEXPECTED BATTERY LONGEVITY AND INDICATED ELECTIVE REPLACEMENT (ERI) IN LESS THAN 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
    59718 VIRTUOSO VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154VWC

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD