BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3860901 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06792
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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: PRODUCT ID ADDR01 IPG, IMPLANTED: (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS FAR FIELD R-WAVE (FFRW) AND THE PATIENT NOTED FEELING DIAPHRAGMATIC STIMULATION. THERE WAS ALSO SUDDEN INCREASE IN ATRIAL CAPTURE THRESHOLD AND A DROP IN P WAVES. IT WAS ALSO REPORTED THERE WAS HIGH THRESHOLD ON THE RIGHT VENTRICULAR (RV) LEAD. BOTH LEADS WERE PARTIALLY EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342654 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4067-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR Hospitalization| R 4965-25 LEAD