BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARQUIS VR

    MDR report key: 1925915 · Received December 14, 2010

    Report

    Report Number
    6000094-2010-02298
    Event Type
    Injury
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S29
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    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.

    Additional Manufacturer Narrative · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME TO THE HOSPITAL BECAUSE OF RECEIVING SHOCKS DUE TO T-WAVE OVERSENSING. THE DEFIBRILLATOR WAS EXPLANTED AND REPLACED. THE RIGHT VENTRICULAR PACE/SENSE LEAD IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME TO THE HOSPITAL BECAUSE OF RECEIVING SHOCKS DUE TO T-WAVE OVERSENSING AND DECREASED R-WAVE SENSING. THE DEFIBRILLATOR WAS EXPLANTED AND REPLACED. THE PACE/SENSE PORTION OF THE RIGHT VENTRICULAR LEAD WAS CAPPED, AND A NEW PACE/SENSE LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUIS VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. 7230CX ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 6949 IMPLANTABLE TACHY LEAD