BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVO MRI SURESCAN

    MDR report key: 2952073 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01664
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWP
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 DURING AN IMPLANT PROCEDURE, THE RIGHT VENTRICULAR LEAD WAS DIFFICULT TO PLACE WITH ACCURATELY-MEASURED R WAVES. THE R WAVES MEASURED DIFFERENTLY WHEN THE LEAD WAS CONNECTED TO THE ANALYZER THAN WHEN THE LEAD WAS CONNECTED TO THE DEVICE. THE PHYSICIAN WAS UNHAPPY WITH THE R WAVE MEASUREMENTS THROUGH THE DEVICE BECAUSE IT ALWAYS MEASURED LESS THAN HALF OF WHAT WAS MEASURED BY THE ANALYZER. THE LEAD AND DEVICE WERE BOTH IMPLANTED AND REMAIN 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
    55669 REVO MRI SURESCAN PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MED REL MEDTRONIC PUERTO RICO RVDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR