BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1990538 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02055
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    April 26, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4), THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. VENTRICULAR PACING ONLY 0.3% OF THE TIME AND ATRIAL PACING IS NEARLY 0.0%. VARIABLE THRESHOLDS AND SENSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE EPISODES OF HIGH RATE EVENTS AND THERE WAS CONCERN WITH REGARD TO LEAD INTEGRITY. THE PATIENT WAS REPORTEDLY PRESYNCOPAL. THE LEAD REMAINS 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 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| O| R (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) IMPLANTABLE LOOP RECORDER| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR