BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITA II DDDR

    MDR report key: 3862435 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01381
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DXY
    PMA / PMN Number
    P990001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 AT THE DEVICE FOLLOW UP, THE PATIENT COMPLAINED OF POCKET STIMULATION. IT WAS ALSO REPORTED THAT THE DEVICE HAD EXPERIENCED A POWER ON RESET (POR) AND REQUIRED REPROGRAMMING TO A LOW OUTPUT AND A RATE OF 40 PPM TO AVOID PACING. THE DEVICE REMAINS IN USE AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338180 VITA II DDDR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY IPG MFG SWITZERLAND VA830U

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention COMPETITOR LEADS X2