BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 3152298 · Received June 7, 2013

    Report

    Report Number
    6000094-2013-00060
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    April 27, 2013
    Manufacturer
    MEDTRONIC S.A. (SMO)
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE FOUND A HIGH CURRENT DRAIN CONDITION DUE TO CURRENT LEAKAGE IN A CERAMIC CAPACITOR.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT: 5554 IMPLANTABLE PACING LEAD (B)(6) 2002. CONCOMITANT PRODUCT: 6947 IMPLANTABLE PACING LEAD (B)(6) 2008.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE IS SUSPECTED OF REACHING PREMATURE BATTERY DEPLETION. IT WAS ALSO REPORTED THAT NOISE WAS OBSERVED ON THE RIGHT ATRIAL (RA) LEAD. THE DEVICE WILL BE REPLACED SOON AND THE RA LEAD REMAINS IN USE AND IS BEING FOLLOWED UP. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252882 VIRTUOSO DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC S.A. (SMO) D164AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R