BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVO MRI SURESCAN

    MDR report key: 2964842 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02301
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    November 21, 2012
    Report Date
    December 10, 2012
    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
    CA, 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 THAT THEY ARE EXPERIENCING FLUCTUATIONS IN BOTH HEART RATE AND BLOOD PRESSURE. BOTH ARE OFTEN DROPPING. THEY ARE OFTEN NOT FEELING WELL, FEELING DIZZY AND EXPERIENCING HEADACHES AND AT ONE TIME THE PATIENT HAD A "SLIGHT PAIN IN THEIR HEART". THIS HAS BEEN ONGOING SINCE THE IMPLANT. THE DEVICE HAS BEEN REPROGRAMMED AND THEIR MEDICATION HAS BEEN ADJUSTED. THE PATIENT BELIEVES THAT THE DEVICE IS MALFUNCTIONING. FOLLOW UP IS BEING CONDUCTED TO FIND OUT IF THERE ARE ANY MALFUNCTIONS OF THE DEVICE. THE DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69115 REVO MRI SURESCAN PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MED REL MEDTRONIC PUERTO RICO RVDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention 5086 X 2 IMPLANTABLE PACING LEADS