BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREEPI

    MDR report key: 3781302 · Received April 30, 2014

    Report

    Report Number
    2182208-2014-01182
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    March 13, 2014
    Report Date
    October 12, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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: ADDR01 IPG IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT ATRIAL AND RIGHT VENTRICULAR HAD IMPEDANCE LEVELS LESS THAN 200 OHMS. IT WAS FURTHER REPORTED THE RIGHT VENTRICULAR LEAD HAD RISING THRESHOLDS. THE LEADS WERE CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE VENTRICULAR LEAD IMPEDANCE SHOWS STEADILY DECREASING VALUES AND THE ATRIAL LEAD HAD A SUDDEN DROP IN IMPEDANCE. A LEAD WARNING OCCURRED ON BOTH ATRIAL AND VENTRICULAR LEADS FOR SHORT-CIRCUIT PACES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258924 CAPSUREEPI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC, INC. 4965-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00009 YR Hospitalization| R