BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREEPI

    MDR report key: 4060195 · Received September 4, 2014

    Report

    Report Number
    2182208-2014-02478
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 12, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 PRODUCT: 4968 LEAD, IMPLANTED (B)(6) 2007.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RIGHT VENTRICULAR (RV) LEAD ALERT DUE TO LOW IMPEDANCE. IT WAS ALSO NOTED THAT THE RV LEAD HAD INSULATION DAMAGE AND THE PATIENT WAS EXPERIENCING STIMULATION AT THE IMPLANT SITE. THE RV LEAD WAS PARTIALLY REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541104 CAPSUREEPI ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 4968-25

    Patients

    Seq Age Sex Outcome Treatment
    1 00008 YR Hospitalization| R ADDRS1 IPG