BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 4162398 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12806
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    January 14, 2014
    Report Date
    November 30, 2022
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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: 6935M-62 LEAD, (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENING FOLLOWING THE SYSTEM IMPLANT THE PATIENT DEVELOPED DIAPHRAGMATIC STIMULATION. A CHEST X-RAY THE FOLLOWING MORNING CONFIRMED DISLODGEMENT OF THE ATRIAL LEAD. INTERROGATION CONFIRMED ELEVATED THRESHOLD AND SMALLER P WAVES. THE PATIENT WAS BROUGHT BACK TO THE ELECTROPHYSIOLOGY LAB AND THE ATRIAL LEAD WAS SUCCESSFULLY REPOSITIONED. IT WAS NOTED THE PATIENT WAS PART OF THE PRODUCT SURVEILLANCE REGISTRY STUDY. THE 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
    639843 CAPSURE SENSE PERMANENT PACEMAKER ELECTRODE DTB MPRI 457453

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Male Hospitalization| R DDBB1D4 ICD| DDBB1D4 ICD