BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SENSE LEAD MRI SURESCAN

    MDR report key: 13439750 · Received February 3, 2022

    Report

    Report Number
    2649622-2022-02420
    Event Type
    Malfunction
    Date Received
    February 3, 2022
    Date of Event
    January 17, 2022
    Report Date
    February 3, 2022
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00643169410916
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCTS: 694965 IMPLANTED ON (B)(6) 2005; 4351-35 GASTRIC MGU LEAD;4351-35 GASTRIC MGU LEAD; 37800 GASTRIC MGU IPG IMPLANTED ON (B)(6) 2016. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES. THE RA 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
    1290478 CAPSURE SENSE LEAD MRI SURESCAN PERMANENT PACEMAKER ELECTRODE DTB MPRI 457445 00643169410916

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male DDMB1D1 ICD