BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 2051749 · Received April 12, 2011

    Report

    Report Number
    2182208-2011-00529
    Event Type
    Injury
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S034
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ATRIAL LEAD HAD DISLODGED PARTIALLY INTO THE VENTRICLE. THIS CONDITION WAS NOTICED WHEN THE VENTRICLE WAS BEING PACED DURING ATRIAL PACING AND THE APPEARANCE OF VENTRICULAR SIGNALS FROM THE ATRIAL ELECTROGRAM CHANNEL. A CHEST X-RAY WAS DONE BUT THIS WAS INCONCLUSIVE. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SENSE IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4574 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R