BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARQUIS VR

    MDR report key: 1072756 · Received July 10, 2008

    Report

    Report Number
    6000094-2008-00308
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    April 22, 2008
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    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 WHERE THE SAME MODEL IS DISTRIBUTED. 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. EVALUATION SUMMARY: NO ANOMALIES WERE FOUND; NO ANOMALIES FOUND; THERE IS ONLY ONE SET OF SETSCREW MARKS ON THE IS-1 CONNECTOR PIN OF THE LEAD AND IT IS TOO PROXIMAL WHICH INDICATES THE LEAD WAS NOT FULLY INSERTED INTO THE DEVICE. FULL LEAD WAS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    ASKU

    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 Other| R