BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3862160 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07028
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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: A 5068-52 LEAD, IMPLANTED: (B)(6) 2000. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOTED TO BE SYMPTOMATIC WITH PRE-SYNCOPE, "HEAD RUSH", AND "CHEST THUMPING" FOR APPROXIMATELY FOUR MONTHS. THE ATRIAL LEAD WAS NOTED TO HAVE TRIGGERED A LEAD WARNING FOR HIGH IMPEDANCE PACES. WHILE IN CLINIC, OVERSENSING WAS NOTED WHEN THE PATIENT WAS POSITIONED LEFT ARM TO RIGHT SHOULDER. THE DEVICE WAS PROGRAMMED TO VVI MODE AND THE PATIENT REPORTS FEELING BETTER WITH NO FURTHER SYMPTOMS. THE LEAD REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339819 CAPSUREFIX DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 4068-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention ADDR01 IPG