BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVO MRI SURESCAN

    MDR report key: 3864810 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11359
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    April 30, 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
    US
    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 PRODUCT: 5086MRI52 LEAD, IMPLANTED: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT'S SPOUSE REPORTED THAT, SINCE THE IMPLANT, THE PATIENT HAS BEEN TO THE EMERGENCY ROOM MULTIPLE TIMES. THE PATIENT EXPERIENCED SHORTNESS OF BREATH, TROUBLE WALKING, AND HAD SOME HALLUCINATIONS. THEY FEEL THAT THE IMPLANTABLE PULSE GENERATOR (IPG) IS SET TOO HIGH FOR THE PATIENT AND IS HAVING SYMPTOMS WHEN IT IS SET AT THAT RATE. REPROGRAMMING HAS BEEN PERFORMED AND 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
    337903 REVO MRI SURESCAN PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MED REL MEDTRONIC PUERTO RICO RVDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention 5086MRI58 LEAD