BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 4314716 · Received December 10, 2014

    Report

    Report Number
    2649622-2014-15156
    Event Type
    Malfunction
    Date Received
    December 10, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING OF P WAVES. THE LEAD WAS NOT IMPLANTED. THE PHYSICIAN ASKED FOR A SECOND LEAD, WHICH ALSO EXHIBITED UNDERSENSING OF P WAVES AT SIMILAR SITES IN THE ATRIUM. THE PHYSICIAN ELECTED TO KEEP THE SECOND LEAD 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
    802680 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI45

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR