BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SENSE

    MDR report key: 1991763 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02540
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 29, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S034
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANT WAS ATTEMPTED, BUT WAS UNSUCCESSFUL DUE TO PATIENT ANATOMY. THE VENTRICULAR LEAD WAS ABLE TO ADVANCE, BUT NOT THE ATRIAL LEAD. BOTH LEADS WERE REMOVED AND DISCARDED. A NEW LEAD WAS PLACED. 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 PUERTO RICO, INC. 4574 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other