BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2810874 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16062
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 5, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 DURING THE PROCEDURE, THE RIGHT ATRIAL (RA) LEAD WAS REPOSITIONED MULTIPLE TIMES DUE TO LEAD FALLING OUT AFTER SCREW DEPLOYMENT. AFTER CLOSING THE PATIENT POCKET, AND WHILE BANDAGING, IT WAS NOTED THAT THE ATRIUM WAS IN ATRIAL FLUTTER. UNDER FLUOROSCOPY, IT WAS NOTED THAT THE LEAD DISLODGED AGAIN. IT WAS DECIDED TO REMOVE THE ATRIAL LEAD, PIN PLUG THE ATRIAL PORT AND PROGRAM THE DEVICE TO VENTRICULAR PACE/SENSE ONLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R VEDR01 IMPLANTABLE PULSE GENERATOR| 4074 IMPLANTABLE PACING LEAD