BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARQUIS VR

    MDR report key: 1990144 · Received February 15, 2011

    Report

    Report Number
    6000094-2011-00207
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    November 20, 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. THE LEAD IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE DISTAL CONDUCTOR FRACTURED. IT WAS NOTED THAT THE DEFIBRILLATION CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON SEVERAL CONDUCTORS (NOT OBSTRUCTED), THE OUTER TUBING OVERLAY WAS BREACHED CUT, THERE WAS A WHITE SUBSTANCE ON THE EXPOSED DEFIBRILLATION COIL, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THE HELIX WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM (SLEEVE HEAD). (B)(4): ANALYSIS FOUND THAT A POWER ON RESET (POR) OCCURRED DUE TO THE DEVICE ATTEMPTING TO PACE FASTER THAN THE VENTRICULAR RATE LIMIT. THE DEVICE INHIBITED THIS ATTEMPT AND THE MICROPROCESSOR WAS RESET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A POWER-ON RESET. IT WAS FURTHER REPORTED THERE WAS OVERSENSING AND INAPPROPRIATE THERAPY DUE TO THE RIGHT VENTRICULAR LEAD. IT WAS NOTED THAT THERE WAS A STENOSIS OF THE PATIENT'S LEFT SUBCLAVIAN VEIN. THE DEVICE AND LEAD WERE REMOVED AND REPLACED. 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 74 YR Hospitalization| L| R