BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    MDR report key: 11317834 · Received February 11, 2021

    Report

    Report Number
    2649622-2021-02789
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Date of Event
    January 3, 2019
    Report Date
    February 11, 2021
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00681490124812
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: A2DR01 IPG, IMPLANT DATE: (B)(6) 2017; PRODUCT ID: 4351-35 GASTRIC MGU LEAD, IMPLANT DATE: (B)(6) 2019; PRODUCT ID: 4351-35 GASTRIC MGU LEAD, IMPLANT DATE: (B)(6) 2019; PRODUCT ID: 37800 GASTRIC MGU IPG, IMPLANT DATE: (B)(6) 2019. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A FALL. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAS BEEN EXHIBITING SHORT V-V INTERVALS. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED POSSIBLE UNDER-SENSING ON STORED ELECTROGRAMS (EGMS). BOTH THE RV LEAD AND RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208910 CAPSUREFIX NOVUS LEAD MRI SURESCAN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52 00681490124812

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR 5076-45 LEAD