BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVO MRI SURESCAN

    MDR report key: 3151525 · Received June 7, 2013

    Report

    Report Number
    3004209178-2013-08778
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWP
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 A POCKET REVISION WAS DONE DUE TO AN INFECTION POST-IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG). THE SOURCE OF THE INFECTION IS UNKNOWN. THE DEVICE REMAINS IN SERVICE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252202 REVO MRI SURESCAN PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MED REL MEDTRONIC PUERTO RICO RVDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R 5086MRI X2 IMPLANTABLE PACING LEADS