BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 3863071 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-10972
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    November 13, 2013
    Report Date
    November 13, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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: 5086MRI52 IMPLANTABLE PACING LEAD, (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST-IMPLANT, THE PATIENT FELT DIZZINESS AND WAS FOUND UNRESPONSIVE WHEN HAVING AN X-RAY PERFORMED. TELEMETRY STRIPS FROM THE DEVICE SHOWED NO CONDUCTION TO THE VENTRICLE FOR ONE BEAT WHICH OCCURRED HOURLY. REPROGRAMMING WAS PERFORMED. THE DEVICE REMAINS IN USE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD SMALL R-WAVES AND EXHIBITED NO CAPTURE. THE LEAD WAS PROGRAMMED LESS SENSITIVE AND IT REMAINS 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
    338633 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO A2DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention 5086MRI45 IMPLANTABLE PACING LEAD