BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 3861164 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11252
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. CONCOMITANT PRODUCTS: 5076-45 LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE PATIENT'S HEART WAS "DOING ITS OWN THANG [SIC]" AND THAT THERE WAS AN ARRHYTHMIA. THE PATIENT NOTED BEING IN THE EMERGENCY ROOM. WHILE IN THE PHYSICIAN'S OFFICE, THE PATIENT'S HEART RATE JUMPED UP WHEN THE PATIENT GOT UP AND WALKED. THE PATIENT ALSO NOTED FEELING "LOUSIER THAN NORMAL THE LAST 2 DAYS." FOLLOW-UP WITH THE PHYSICIAN'S OFFICE DID NOT YIELD ANY ADDITIONAL RELEVANT INFORMATION REGARDING THIS EVENT. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341894 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. A2DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR 5076-52 LEAD