BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 3862212 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07007
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    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: 407458 LEAD, IMPLANTED (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEWLY IMPLANTED RIGHT ATRIAL (RA) LEAD WAS EXHIBITING NO CAPTURE AND HIGH THRESHOLD MEASUREMENTS. THE LEAD WAS BELIEVED TO HAVE DISLODGED WHEN TRANSFERRING THE PATIENT FROM THE OPERATING ROOM TABLE TO A HOSPITAL BED AND WAS CONFIRMED ON X-RAY. THE LEAD WAS EXPLANTED AND REPLACED WITH AN ACTIVE FIXATION LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343029 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 457453

    Patients

    Seq Age Sex Outcome Treatment
    1 00091 YR Hospitalization| R ADDR01 IPG