BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE

    MDR report key: 3993601 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09225
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    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: MODEL: 4261, COMPETITOR LEAD, IMPLANT: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THEY GET WINDED EASILY, AND AT THEIR LAST OFFICE VISIT THE PHYSICIAN "SAW SOMETHING ON MY LEAD." FOLLOW-UP WITH THE CLINIC REVEALED THAT THERE WAS SOME OVERSENSING NOISE ON THE PATIENTS RIGHT ATRIAL (RA) LEAD. THE RA LEAD SENSITIVITY WAS REPROGRAMMED AND 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
    472661 CAPSURE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4504M53

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention ADDR01, IPG