BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 1991219 · Received February 15, 2011

    Report

    Report Number
    6000094-2011-00254
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    Z-0130-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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 THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY (B)(4) 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. THE LONGEVITY MET 53% OF EXPECTED BATTERY LIFE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS REPLACED AS IT HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT). THE PATIENT HAD RECEIVED RADIATION THERAPY IN THE PECTORAL REGION BUT THERE WERE NO OTHER ANOMALIES REGARDING THE DEVICE. THE REPORTER SUSPECTED PREMATURE BATTERY DEPLETION AS THE DEVICE HAD BEEN IMPLANTED FOR LESS THAN 4 YEARS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. D164AWG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R