BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERA-I DR

    MDR report key: 2131428 · Received June 16, 2011

    Report

    Report Number
    2647346-2011-00872
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    January 1, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S37
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN ADDITION TO FEELING TIRED AND DIZZY THE PATIENT HAS NOTICED A VIBRATION IN THE AREA OF THE PACEMAKER. THE DEVICE 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
    1 THERA-I DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. 7962IB ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD