BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVO MRI SURESCAN

    MDR report key: 2952667 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01787
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    September 24, 2012
    Report Date
    November 26, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWP
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. CONCOMITANT PRODUCT: (B)(4), IMPLANTABLE PACING LEAD, (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE AND LEADS WERE REMOVED DUE TO INFECTION. THE SYSTEM WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57817 REVO MRI SURESCAN PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MED REL MEDTRONIC PUERTO RICO RVDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| R (B)(4) IMPLANTABLE PACING LEAD