BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 5104649 · Received September 25, 2015

    Report

    Report Number
    3004209178-2015-18743
    Event Type
    Death
    Date Received
    September 25, 2015
    Date of Event
    August 20, 2015
    Report Date
    August 30, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED FROM SEPTIC SHOCK AND WAS HOSPITALIZED AT THE TIME OF DEATH. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY NINE MONTHS POST IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT. THE CALLER INQUIRED WHAT NEEDED TO BE DONE WITH THE PACEMAKER. THERE WAS NO ALLEGATION ON THE PRODUCTS AND MULTIPLE ATTEMPTS AT FOLLOW-UP FOR EVENT CLARIFICATION WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637032 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. A2DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00094 YR Death 5076-52 LEAD, 1688T LEAD