BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVO MRI SURESCAN

    MDR report key: 3862504 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11068
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 5, 2014
    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 Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    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 PRODUCT: 5086MRI52, LEAD, (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH HYPOTENSION AND SYNCOPE. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) SHOWED POSSIBLE THROMBUS/VEGETATION. A FOLLOW-UP TEE WAS CLEAR BUT THE PATIENT DID HAVE A PULMONARY EMBOLISM. THE PATIENT WAS NOTED TO HAVE A LOW HEART RATE WHILE IN THE HOSPITAL. THE DEVICE WAS REPROGRAMMED DUE TO THE PATIENT¿S CHRONIC ATRIAL FIBRILLATION AND THE LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339402 REVO MRI SURESCAN PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MED REL MEDTRONIC PUERTO RICO RVDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R 5086MRI45 LEAD