BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5724661 · Received June 14, 2016

    Report

    Report Number
    3004209178-2016-12174
    Event Type
    Injury
    Date Received
    June 14, 2016
    Report Date
    June 14, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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 PROVIDER VIA A COMPANY REPRESENTATIVE IN REGARDS TO A PATIENT WHO WAS BEING TREATED WITH BACLOFEN INTRATHECAL (TYPE, DOSE, CONCENTRATION, AND LOT # UNKNOWN). THE INDICATION FOR USE WAS INTRACTABLE SPASTICITY AND MULTIPLE SCLEROSIS. PER THE SURGEON'S OFFICE, BEGINNING AT AN UNKNOWN TIME, THE PATIENT HAD ONGOING PAIN IN THE PUMP AREA. THERE WERE NO KNOWN ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE SURGEON PLANNED TO RELOCATE THE PUMP AND DOWNSIZE THE PUMP TO A 20 CC PUMP, PER THE PATIENT'S REQUEST. THE ISSUE HAD NOT RESOLVED AS OF THE DATE OF THIS REPORT, BUT THE PATIENT'S STATUS WAS "ALIVE - NO INJURY." THE PATIENT HAD A MEDICAL HISTORY OF MULTIPLE SCLEROSIS. THE SURGICAL INTERVENTION HAD NOT OCCURRED, BUT IT WAS SCHEDULED FOR (B)(6) 2016. INFORMATION REGARDING THE CAUSE OF THE ISSUE, ADDITIONAL MEDICATIONS TAKEN AT THE TIME OF THE EVENT, ADDITIONAL TROUBLESHOOTING, AND THE OUTCOME WERE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. THE PATIENT WAS RECEIVING UNKNOWN INTRATHECAL BACLOFEN 500MCG/ML, 154.97MCG/DAY. MEDICAL HISTORY INCLUDES MULTIPLE SCLEROSIS, ARTHRITIS, HYPERTENSION, HYPERLIPEMIA, AND DIVERTICULITIS. THERE WERE NO KNOWN DRUG ALLERGIES. THE PATIENT STATED THAT THE DISCOMFORT WAS FROM THE TIP OF THE CATHETER ACCESS PORT (CAP) POKING, AND IT STARTED P OKING HER SHORTLY AFTER IMPLANT. A POCKET REVISION WAS PERFORMED ON (B)(6) 2016 AND IT WAS UNKNOWN YET IF THE PAIN HAD RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377460 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention