BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 3864836 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11351
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    June 27, 2013
    Report Date
    April 29, 2014
    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
    PA, 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 PRODUCT: 5086MRI45 LEAD IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CALLED TO REPORT "IT IS UNCOMFORTABLE, DRIVES ME CRAZY, AND SLIDES AROUND. IT'S A RAW, SORE PAIN IN THE DEVICE AREA. I TALKED TO THE SURGEON TO HAVE IT REMOVED OR CHECK IT OUT TO SEE WHAT OPTIONS I HAVE. FEELS LIKE A POCKET FULL OF PUS...HURTS ALL AROUND AND UNDER ARM PIT. CAN'T LIE ON LEFT SIDE BECAUSE THE DEVICE PUSHES ON MY SHOULDER." FOLLOW UP DETERMINED THE PATIENT HAD BEEN SEEN BY THE CLINIC FOLLOWING THE PATIENT CALL. THE PATIENT DID NOT MENTION ANY REPORT OF PAIN AT IMPLANT SITE AND NO REPORT OF ANY OTHER SYMPTOMS. THERE WAS NO PERFORMANCE ALLEGATION AGAINST THE DEVICE. THE PATIENT CALLED BACK AGAIN AND REPORTED "THEY GUARANTEED THAT I WOULD GET ACCUSTOMED TO IT, WELL I NEVER DID. IT'S BEEN TRAVELING THROUGHOUT MY CHEST. IT'S DRIVNG ME INSANE. IT'S PRESSING ON A NERVE I THINK. THEY SCHEDULED ME TO HAVE A REPLACEMENT." FOLLOW UP CONFIRMED THE PATIENT WAS REFERRED TO CARDIOTHORACIC SURGEON TO PUT THE DEVICE SUB-PECTORAL. 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
    338169 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO A2DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R 5086MRI52 LEAD