BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO VR

    MDR report key: 1791490 · Received August 10, 2010

    Report

    Report Number
    6000094-2010-01442
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    December 22, 2009
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. EVALUATION SUMMARY: (B)(4) A LOW BATTERY VOLTAGE WAS MEASURED; HOWEVER, ELECTRICAL ANALYSIS DID NOT FIND ANY ANOMALIES WITHIN THE DEVICE OR THE HYBRID. THE HYBRID HAD NOMINAL CURRENT DRAIN. LONG TERM MONITORING AT 23C AND 37C TEMPERATURES, ELECTRICAL BENCH TESTING, AND TEMPERATURE CYCLING WERE PERFORMED. NO HIGH CURRENT OR ABNORMAL CONDITIONS WERE OBSERVED, AND THE CAUSE OF THE BATTERY DEPLETION WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE DEVICE WAS REPLACED 1 YEAR AFTER IMPLANT DUE TO A LOW BATTERY VOLTAGE. THE DEVICE WAS EXPLANTED AND REPLACED AT THE SAME TIME AS THE RIGHT VENTRICULAR LEAD. 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 NIK MEDTRONIC S.A. D164VWC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention