BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO

    MDR report key: 4161684 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19018
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    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
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. A HIGH CURRENT DRAIN CONDITION WAS FOUND DURING DEVICE ANALYSIS. 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 FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEADS EXHIBITED UNSTABLE IMPEDANCES AND INSULATION DAMAGE. THE LEADS WERE CAPPED AND REPLACED, AND THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED RECOMMENDED REPLACEMENT TIME (RRT), AND THE PHYSICIAN FELT THAT THE DEVICE WOULD LAST LONGER. THE DEVICE WILL BE 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
    639023 VIRTUOSO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154VWC

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R 6933 LEAD, 6936 LEAD