BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVO MRI SURESCAN

    MDR report key: 3153298 · Received June 8, 2013

    Report

    Report Number
    3004209178-2013-08905
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    January 24, 2013
    Report Date
    March 6, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWP
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. CONCOMITANT PRODUCTS: PRODUCT ID 5086MRI52 X2 IMPLANTABLE PACING LEADS (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD IMPEDANCE WAS HIGH AND THERE WAS NO CAPTURE AT MAXIMUM OUTPUT. THE PATIENT INDICATED HAVING TWO FALLS POST SURGERY. WHEN THE PATIENT'S POCKET WAS OPENED DURING THE LEAD REVISION PROCEDURE, THE LEAD WAS NOTED TO FALL OUT OF THE HEADER. THE LEAD TESTED NORMAL AND THEN WAS RESEATED IN THE DEVICE. 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
    255027 REVO MRI SURESCAN PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MED REL MEDTRONIC PUERTO RICO RVDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| R