BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 8253857 · Received January 16, 2019

    Report

    Report Number
    3004209178-2019-01123
    Event Type
    Injury
    Date Received
    January 16, 2019
    Date of Event
    January 9, 2019
    Report Date
    January 31, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BY A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN SPINAL P AIN. IT WAS REPORTED THAT THE PATIENT NOTED DIARRHEA, SHORTNESS OF BREATH AND LIGHT-HEADEDNESS ON (B)(6) 2019, WHICH CONTINUED OVER THE NEXT SEVERAL DAYS. ON (B)(6) 2019 THE PATIENT WAS VERY COLD AND NOTED PUS COMING OUT OF THEIR GENERATOR INCISION. THEY CALLED THE NEUROSURGERY SERVICE AND WAS TAKEN BY AMBULANCE TO THE HOSPITAL. THE PATIENT WAS SEEN BY THEIR DOCTOR¿S PARTNER, WHO EXPLANTED THEIR DEVICE ON (B)(6) 2019 ONCE THE PATIENT¿S BLOOD PRESSURE WAS UNDER CONTROL AS IT WAS AT 200/115 ON ADMISSION PER THE PATIENT. NO KNOWN FACTORS LED OR CONTRIBUTED TO THE ISSUE. THE PATIENT¿S GENERATOR AND LEAD WERE EXPLANTED DUE TO INFECTION AND THE PATIENT WAS ON IV ANTIBIOTICS. IT WAS REPORTED THAT THE PATIENT WOULD BE SENT HOME ON ANTIBIOTICS. THE PATIENT WOULD BE SEEN IN FOUR WEEKS TO ASSESS OPTIONS OF RE-IMPLANTING THEIR DEVICE. IT WAS REPORTED THAT THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THE DEVICE WOULD NOT BE RETURNED FOR ANALYSIS AS THE CUSTOMER DISCARDED IT. THE EVENT OCCURRED ON (B)(6) 2019. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47621 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R