BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 2791233 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14511
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S27
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 THE PATIENT COULD FEEL THE VENTRICULAR PACING. IT WAS ALSO REPORTED THAT THE UNIPOLAR IMPEDANCE WAS HIGHER THAN THE BIPOLAR IMPEDANCE. THE LEAD WILL BE MONITORED AND 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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other KDR801 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4068 IMPLANTABLE PACING LEAD