BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE VDD 2

    MDR report key: 3992930 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09584
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    April 3, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MPRI
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 THE IMPLANTABLE PULSE GENERATOR (IPG) ENCOUNTERED A CHARGE TIME OUT AND WAS EXPLANTED AND REPLACED. THE ATRIAL LEAD EXHIBITED OVERSENSING, WAS CAPPED AND NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468503 CAPSURE VDD 2 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MPRI 5038

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SVDD303 IPG