BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREEPI

    MDR report key: 3830804 · Received May 23, 2014

    Report

    Report Number
    2182208-2014-01199
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 30, 2014
    Report Date
    October 8, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT RV LEAD IMPEDANCE WAS 171 OHMS. CAPTURE THRESHOLD WAS <(><<)>[email protected]. IT WAS NOTED THAT THE PATIENT RECENTLY HAD VALVE SURGERY. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    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: C4TR01 IPG IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT¿S PARENT AND THE CLINICIAN THAT THE DEVICE LONGEVITY DECREASED FROM A PREDICTED SIX AND ONE-HALF YEARS TO TWO YEARS IN A SPAN OF NINE WEEKS. IT WAS FURTHER REPORTED THAT THE PATIENT COMPLAINTS OF DIZZINESS AND LIGHT HEADEDNESS AND THE RIGHT VENTRICULAR LEAD IS FRACTURED. THE DEVICE AND LEAD REMAIN IN USE. THE PATIENT WILL RETURN TO THE CLINIC FOR FOLLOW UP. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE LEAD AND DEVICE WERE REPLACED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT A REVIEW OF HOLTER MONITOR DATA NOTED T-WAVE OVERSENSING (TWOS) AND INTERMITTENT LOSS OF CAPTURE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307643 CAPSUREEPI ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 4968-25

    Patients

    Seq Age Sex Outcome Treatment
    1 00013 YR Hospitalization| R