BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    MDR report key: 3993190 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09444
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 12, 2014
    Report Date
    January 20, 2021
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. CONCOMITANT: SEDR01 IPG IMPLANTED: 2008-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INDECIPHERABLE DUAL ELECTROGRAMS WERE FOUND ON THE REMOTE PACEMAKER TRANSMISSION. THE DEVICE REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH THRESHOLD MEASUREMENT, WHICH APPEARS TO HAVE BEEN TRENDING FOR SOME TIME. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468902 CAPSUREFIX NOVUS LEAD MRI SURESCAN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR 5076-52 LEAD| 5076-52 LEAD