BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2790536 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15034
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 PATIENT REPORTED FEELING THEIR HEART RACING. IT WAS ALSO REPORTED THAT THE ATRIAL HISTOGRAM SHOWED A RATE DISTRIBUTION BETWEEN 70-110 BPM. IT WAS FURTHER REPORTED THAT THE RATE RESPONSE HAS REMAINED UNCHANGED AND AT THE PATIENT'S LAST CHECK THE ATRIAL SENSITIVITY WAS MADE MORE SENSITIVE. THE PATIENT WILL RETURN FOR ANOTHER CHECK. THE ATRIAL LEAD REMAINS IN USE. 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 63 YR Other 5076 IMPLANTABLE PACING LEAD| P1501DR IMPLANTABLE PULSE GENERATOR