BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    MDR report key: 10187727 · Received June 24, 2020

    Report

    Report Number
    6000030-2020-00174
    Event Type
    Injury
    Date Received
    June 24, 2020
    Date of Event
    May 13, 2020
    Report Date
    June 24, 2020
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED FOR UNKNOWN REASONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. 2020-06-15 - IT WAS FURTHER REPORTED HIGH THRESHOLDS AND HIGH IMPEDANCE WERE NOTED ON THE RV LEAD AND A TEMPORARY PACING WIRE WAS USED DURING THE LASER EXTRACTION. 2020-06-24: IT WAS FURTHER REPORTED THAT RIGHT ATRIAL (RA) LEAD HAD FORMED ADHESIONS TO RV LEAD; THEREFORE, THE RA LEAD WAS ALSO REMOVED IN ORDER TO GET THE RV LEAD OUT. THE RA AND RV LEADS WERE BOTH REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651319 CAPSUREFIX NOVUS LEAD MRI SURESCAN ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R ADDR01 IPG, 5076-58 LEAD, 4092-58