BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1874547 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11432
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    August 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 ATRIAL LEAD IS NOT CAPTURING. THE LEAD IS SENSING BUT THE P-WAVES ARE NOW LOWER THAN AT IMPLANT. IT WAS ALSO REPORTED THAT THE PATIENT HAD AN ATRIAL INFARCT. THE DEVICE WAS PROGRAMMED VVD. THE LEAD IS STILL 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. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention (B)(4) IMPLANTABLE PULSE GENERATOR| 4074 IMPLANTABLE PACING LEAD