BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 7722351 · Received July 26, 2018

    Report

    Report Number
    3007566237-2018-02217
    Event Type
    Injury
    Date Received
    July 26, 2018
    Date of Event
    July 16, 2018
    Report Date
    October 4, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    GZJ
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT IN A CLINICAL STUDY WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPERTENSION, NAUSEA, AND VOMITING POST-IMPLANT PROCEDURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR MONITORING OVERNIGHT. THE FOLLOWING MEDICATIONS WERE ADMINISTERED: 30 MG LABETALOL, 5MG IV HYDRALAZINE, 1 MG IV HYDROMORPHONE, 1 MG IV HALOPERIDOL AND MG PO OLANZAPINE. IT WAS NOTED THAT THE BP WAS IN NORMAL RANGE, THE VOMITING CEASED ON (B)(6) 2018, AND THE NAUSEA DECREASED LATER IN THE EVENING. THE PATIENT HAD A POOR APPETITE FOR DAYS PRIOR TO THE SURGERY, A HISTORY OF HYPERTENSION, AND HAD BEEN OFF LISINOPRIL FOR 2 DAYS PRIOR TO THE PROCEDURE. THE PLAN WAS FOR EXTRA DOSE OF AMLODIPINE ON 7/16 PM, THEN CONTINUE HOME DOSE LISINOPRIL, PRN LABETALOL FOR SBP>180, PRN ONDANSETRON IF THE NAUSEA CONTINUED. IT WAS NOTED THAT THE NAUSEA WAS LIKELY RELATED TO THE ANESTHETICS AND OPIATES, AND THE EVENT WAS NOT RELATED TO THE DEVICE OR THERAPY AND RELATED TO THE IMPLANT PROCEDURE/SURGERY/ANESTHESIA. THE PATIENT WAS RELEASED TO GO HOME ON (B)(6) 2018 AND THE EVENT RESOLVED WITHOUT SEQUELAE. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566458 INTELLIS GZJ MEDTRONIC PUERTO RICO OPERATIONS CO. 97715

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization