BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREEPI

    MDR report key: 3952647 · Received July 23, 2014

    Report

    Report Number
    2182208-2014-01863
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P950024
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH SYMPTOMATIC BRADYCARDIA AND WAS FOUND TO BE IN SECOND DEGREE HEART B LOCK. THE IPG BATTERY WAS DEPLETED AND THE DEVICE WAS UNABLE TO BE INTERROGATED. THE LEADS WERE TESTED THROUGH THE PACING SYSTEM ANALYZER AND REVEALED HIGH THRESHOLDS AND NO CAPTURE AT MAXIMUM OUTPUT WITH THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD AS WELL AS OVERSENSING (TRIPLE SENSING EVERY BEAT) ON THE RA LEAD. THE IPG WAS EXPLANTED AND THE LEADS WERE PARTIALLY EXPLANTED. A NEW IPG SYSTEM WAS 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
    431968 CAPSUREEPI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC, INC. 4965-15

    Patients

    Seq Age Sex Outcome Treatment
    1 00009 YR Hospitalization| R 4965-15 LEAD, E2DR21AA IPG