BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1925387 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13829
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    September 28, 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
    NY, US
    Reporter Occupation
    RISK MANAGER

    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 THE PATIENT PRESENTED WITH COMPLAINTS OF DIZZINESS AND FAINTING. LOW RATES WERE OBSERVED. PAUSES WERE ALSO OBSERVED AND WERE REPEATABLE WITH POCKET MANIPULATION. OVERSENSING AND NOISE WERE SEEN ON BOTH THE ATRIAL AND VENTRICULAR LEADS. CALLER ALSO HAD QUESTIONS ABOUT THE HEADER BLOCK FOR THE DEVICE. THE DEVICE AND THE LEADS WERE REPLACED. NO FURTHER 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| O| R