BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 4161766 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11411
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 28, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: 457445 LEAD, IMPLANTED (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD MEASURED HIGH IMPEDANCE. CAPTURE THRESHOLDS HAD VARIED EVEN THOUGH IT CURRENTLY MEASURED WITHIN NORMAL RANGE. THE LEAD WAS CAPPED AND WAS REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640736 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407452

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R E2DR01AA IPG