BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVO MRI SURESCAN

    MDR report key: 2790462 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05705
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    August 20, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWP
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    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.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO THE MANUFACTURER AND ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING DISCOMFORT FOLLOWING IMPLANT OF THE DEVICE AND LEADS. IT WAS ALSO REPORTED THAT THE REPORT OF DISCOMFORT BY THE PATIENT WAS UNABLE TO BE REPLICATED WITH MODIFICATION TO PACING OUTPUTS. THEREFORE THE DEVICE AND ATRIAL AND VENTRICULAR LEADS WERE REMOVED AND NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVO MRI SURESCAN IMPLANTABLE PULSE GENERATOR LWP MEDTRONIC MED REL, INC. RVDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R