BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 8733489 · Received June 26, 2019

    Report

    Report Number
    3004209178-2019-12359
    Event Type
    Injury
    Date Received
    June 26, 2019
    Report Date
    June 26, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    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 PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR LUMBAR RADICULOPATHY. IT WAS REPORTED THAT THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) REMOVED IN 2017 BECAUSE ¿SOMETHING WENT WRONG¿ AND THEY THOUGHT SOMETHING WAS ¿LEAKING¿. THE PATIENT ALSO REPORTED THAT HE STARTED EXPERIENCING A 103-105-DEGREE TEMPERATURE FOR OVER A MONTH AND HAD IRRITATION AT THE INCISION SITE. DOCTORS PERFORMED BLOOD TESTS BUT COULDN'T FIND ANYTHING WRONG. IT WAS THEN DECIDED THAT THE DEVICE WOULD BE REMOVED AND IN RESULT, THE IRRITATION AND FEVERS WENT AWAY. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526710 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention