BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 6144577 · Received December 5, 2016

    Report

    Report Number
    3004209178-2016-25125
    Event Type
    Death
    Date Received
    December 5, 2016
    Date of Event
    November 7, 2016
    Report Date
    November 7, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS REMOVED DUE TO SEPTIC INFECTION. IT WAS LATER REPORTED BY THE CLINIC, THAT THE PATIENT PASSED AWAY NINE DAYS LATER. NO ADDITIONAL INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796090 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. A2DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death 507652 LEAD, 507658 LEAD