BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE DRUG INFUSION PUMP

    MDR report key: 11367172 · Received February 23, 2021

    Report

    Report Number
    2182207-2021-00303
    Event Type
    Injury
    Date Received
    February 23, 2021
    Date of Event
    February 4, 2021
    Report Date
    February 23, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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 HEALTHCARE PROFESSIONAL (HCP) VIA SAOL THERAPEUTICS REGARDING A PATIENT RECEIVING LIORESAL UNKNOWN C ONCENTRATION FOR A TOTAL DOSE OF 1000 MCG/DAY VIA AN IMPLANTABLE PUMP. IT WAS REPORTED FOLLOWING PUMP REPLACEMENT ON (B)(6) 2021, THE PATIENT WAS NAUSEOUS THROUGHOUT THE DAY SO PHENERGAN AND ZOFRAN WERE ADMINISTERED. THE PATIENT WAS ALSO TIRED/SOMNOLENT, BUT EASILY AROUSABLE. THE PATIENT WAS ASLEEP AND THE HCP WOULD HAVE TO WAKE THEM UP. THE PATIENT'S MOTHER ALSO COMMENTED ON THE SLEEPINESS. IT WAS ALSO NOTED THAT THE PATIENT'S HAD A HEART RATE OF 60, AND BASELINE BEFORE ADMISSION WAS 80-85. NO SEIZURES HAVE HAPPENED AND THE HCP DID NOT SEE ANY WITHDRAWAL SYMPTOMS. THE PATIENT'S DOSE WAS REDUCED TO 700 MCG ON (B)(6) 2021 (30% DECREASE), AND THE DOSE WAS CUT BACK TO 650 MCG ON (B)(6) 2021. ON (B)(6) 2021 THE PATIENT WAS NOT AGITATED OR CONFUSED. THE PATIENT WAS MUCH MORE ALERT TODAY (2021-FEB-05). THE PATIENT WAS STILL FEELING "A LITTLE FLOPPY" (NOT FURTHER CLARIFIED) AND WOULD BE GETTING PHYSICAL THERAPY. NO FURTHER INFORMATION WAS REPORTED. IT WAS NOTED THE PATIENT WAS CURRENTLY IN THE HOSPITAL. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264884 IMPLANTABLE DRUG INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization