BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    MDR report key: 3863432 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06727
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    November 13, 2012
    Report Date
    November 6, 2020
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 MEDICAL PRODUCTS: 5076-52 LEAD, (B)(6) 2002. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACING THRESHOLDS HAD GREATLY INCREASED IN THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD HAD SUSTAINED FAILURE TO CAPTURE. THE PACING OUTPUTS WERE REPROGRAMMED TO ADJUST FOR SAFETY MARGIN PACING. THE RV 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
    341265 CAPSUREFIX NOVUS LEAD MRI SURESCAN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention C2TR01 IPG, 1258T LEAD| C2TR01 IPG, 1258T LEAD