BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1925344 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13809
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S27
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 THE RIGHT VENTRICULAR LEAD DOES NOT CAPTURE WHEN IN UNIPOLAR CONFIGURATION, UNLESS "EMERGENCY IS PRESSED". IT WAS ALSO NOTED THAT IT WAS NOT POSSIBLE TO OBTAIN AN UNIPOLAR IMPEDANCE MEASUREMENT. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4092 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other ADDR01 IMPLANTABLE PULSE GENERATOR| 5568 IMPLANTABLE PACING LEAD