BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1854859 · Received October 5, 2010

    Report

    Report Number
    2649622-2010-09281
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    November 1, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 IMPEDANCE WAS HIGH SINCE (B)(4) 2009, AND THAT THRESHOLD WAS SLIGHTLY ELEVATED. THE LEAD WAS REMOVED AND REPLACED, HOWEVER THE LEAD WAS UNABLE TO COME OUT OF THE LASER SHEATH USED FOR THE EXTRACTION. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO 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 85 YR Required Intervention KDR901 IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD