BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE VDD

    MDR report key: 3993298 · Received August 8, 2014

    Report

    Report Number
    6000023-2014-00007
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC, B.V.
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE CHANGE OUT FOR NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI), THE LEAD HAD NO CAPTURE AND HIGH IMPEDANCE IN BOTH UNIPOLAR AND BIPOLAR CONFIGURATIONS. THE LEAD WAS CAPPED 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
    470320 CAPSURE VDD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, B.V. 503258

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR Hospitalization| R KVDD701 IPG