BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 3864744 · Received June 10, 2014

    Report

    Report Number
    6000144-2014-00006
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. CONCOMITANT PRODUCT: 5076-52 LEAD, IMPLANTED: (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THEY HAD LOW BLOOD PRESSURE AND THAT THEIR NEW IMPLANTABLE PULSE GENERATOR (IPG) HAD NOT BEEN PROGRAMMED TO THE SAME RATE AS THE PREVIOUS IPG. THE IPG WAS REPROGRAMMED AND 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
    337765 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO A2DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention 5076-45 LEAD