BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2812526 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16685
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    November 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT THE LOW IMPEDANCE AND OVERSENSING HAS CONTINUED. THE DEVICE WAS REPROGRAMMED TO AAIR WITH NO VENTRICULAR BACKUP AND REMAINS IN USE.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT A REMOTE TRANSMISSION SHOWS AN EPISODE OF NOISE ON THE RIGHT VENTRICULAR LEAD. THE LEAD WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAS HAD GRADUALLY DECREASING IMPEDANCE AND IS NOW LOW. THERE IS ALSO OVERSENSING, HIGH THRESHOLD AND A POSSIBLE INSULATION BREACH. THE PHYSICIAN HAS CHOSEN TO MONITOR THE LEAD AND NOT REPLACE IT AT THIS TIME. THE LEAD IS STILL 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 MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC PUERTO RICO, INC. 5086MRI

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| O| R (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) IMPLANTABLE PACING LEAD