BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVO MRI SURESCAN

    MDR report key: 2203453 · Received August 11, 2011

    Report

    Report Number
    6000094-2011-01458
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWP
    PMA / PMN Number
    P090013
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAS BEEN EXPERIENCING CHEST PAINS, DISCOMFORT, PALPITATIONS AND WAKING UP AT NIGHT DUE TO THE PACEMAKER. IT IS ALSO NOTED PATIENT FELT AN ELECTRICAL SHOCK HEAD TO TOE. THE PACEMAKER IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAS BEEN EXPERIENCING CHEST PAINS, DISCOMFORT, PALPITATIONS AND WAKING UP AT NIGHT DUE TO THE PACEMAKER. IT IS ALSO NOTED PATIENT FELT AN ELECTRICAL SHOCK HEAD TO TOE. IT WAS FURTHER REPORTED THAT THE PATIENT COMPLAINED OF FALLING A COUPLE OF TIMES, AND OF BEING HOSPITALIZED DUE TO CONTINUAL PAIN IN THE AREA OF THE DEVICE. THE PATIENT STATED THAT A PHYSICIAN CHECKED THE DEVICE, AND FELT THAT EVERYTHING WAS FINE. FOLLOW UP WAS ATTEMPTED FOR ADDITIONAL INFORMATION BUT WAS UNSUCCESSFUL. THE PACEMAKER IS STILL IN USE. NO PATIENT COMPLICATIONS WERE 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 S.A. RVDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other (B)(4) X2 IMPLANTABLE PACING LEAD| (B)(4) X2 IMPLANTABLE PACING LEADS