BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS LEAD

    MDR report key: 19279295 · Received May 8, 2024

    Report

    Report Number
    MW5154680
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    April 30, 2024
    Report Date
    May 7, 2024
    Manufacturer
    MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE PATIENT PRESENTED WITH ERI PARAMETERS. THE ATRIAL LEAD WAS A CHRONIC MEDTRONIC LEAD WITH LEAD IMPEDANCE OF LESS THAN 100 OHMS AND A CAPTURE THRESHOLD OF 2.75 @ 1.3MS. SUSPECT THE PREMATURE BATTERY DRAIN WAS RELATED TO THE PROGRAMMED PARAMETERS. WE REPLACED THE ATRIAL LEAD AND DEVICE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122718 CAPSURE SP NOVUS LEAD DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 4092

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown