BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVO MRI SURESCAN

    MDR report key: 3071703 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06724
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 25, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWP
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT TWO WEEKS POST IMPLANT THAT THEY WERE STILL VERY SORE AROUND THE SHOULDER AREA. THE PATIENT ALSO SAID THAT AT THE DEVICE CHECK THE PRIOR WEEK THAT THE ELECTROCARDIOGRAM SHOWED SOMETHING NOW QUITE RIGHT SO THE PHYSICIAN SCHEDULED THE PATIENT FOR ANOTHER APPOINTMENT. THE DEVICE IS STILL 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
    171725 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 5086MRI X2 IMPLANTABLE PACING LEADS