BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVO MRI SURESCAN

    MDR report key: 2812604 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06360
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 2, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWP
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THE DEVICE WOULD NOT DISPLAY A BATTERY VOLTAGE. THE BATTERY VOLTAGE DISPLAYED AFTER THE PROGRAMMER WAS TURNED OFF AND ON BUT THEN THE LEAD IMPEDANCE MEASUREMENTS WERE DISPLAYED AS GREATER THAN 3000 OHMS. THE TIME WITHIN THE DEVICE WAS CHANGED TO 2:13AM AND WHEN THE 2:15 AM BATTERY AND LEAD MEASUREMENTS OCCURRED THERE WERE APPROPRIATE IMPEDANCES DISPLAYED. THE DEVICE WAS IMPLANTED AND 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 REVO MRI SURESCAN IMPLANTABLE PULSE GENERATOR LWP MEDTRONIC MED REL, INC. RVDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other (B)(4) X2 IMPLANTABLE PACING LEADS