BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX LEAD

    MDR report key: 13583354 · Received February 23, 2022

    Report

    Report Number
    2649622-2022-03644
    Event Type
    Malfunction
    Date Received
    February 23, 2022
    Date of Event
    October 22, 2021
    Report Date
    February 23, 2022
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    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 MEDICAL PRODUCTS: 506852 LEAD, IMPLANTED: (B)(6) 2000. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 506852 LEAD, IMPLANTED: (B)(6) 2000. 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 FAR FIELD R WAVE OVERSENSING. IT WAS ALSO REPORTED THAT THE RA LEAD EXHIBITED A FAILED POSITION CHECK. THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R WAVE OVERSENSING. IT WAS ALSO REPORTED THAT THE RA LEAD EXHIBITED A FAILED POSITION CHECK. 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
    1006085 CAPSUREFIX LEAD PERMANENT PACEMAKER ELECTRODE DTB MPRI 5568-45

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male W1DR01 IPG