BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 4830320 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-06182
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    March 27, 2015
    Report Date
    March 27, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS EXHIBITING LOW P-WAVES OR DIMINISHED P-WAVES. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377885 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5568-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Hospitalization| R 407652 LEAD, SEDR01 IPG