BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5100852 · Received September 24, 2015

    Report

    Report Number
    3004209178-2015-18594
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    June 4, 2015
    Report Date
    August 31, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(4) 2015, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: CATHETER. (B)(4)

    Description of Event or Problem · 1

    10/20/2015- ADDITIONAL INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE INDICATED THE PATIENT DID NOT HAVE HIS CATHETER SURGICALLY REVISED TO THEIR KNOWLEDGE. NO FURTHER INFORMATION WAS PROVIDED AND THE LOT NUMBER OF LIORESAL WAS UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING INTRATHECAL LIORESAL 2 ,000MCG/ML, 400MCG/DAY, FOR INTRACTABLE SPASTICITY. THE PATIENT HAD NO CHANGE IN SPASTICITY SYMPTOMS SINCE IMPLANT ON (B)(6) 2015. A CATHETER DYE STUDY WAS PERFORMED ON (B)(6) 2015 AND IT WAS NOT POSSIBLE TO ASPIRATE THE CATHETER; CATHETER REPLACEMENT OCCURRED (B)(6) 2015. OTHER MEDICATIONS THE PATIENT WAS TAKING AT THE TIME OF THE EVENT INCLUDED BACLOFEN (ORAL) 10MG TID; FLUOXETINE (ORAL) 20MG QAM; ASPIRIN (ORAL) 325MG QAM; LISINOPRIL (ORAL) 40MG QD; METFORMIN HCL (ORAL) 500MG BID; PRAVASTATIN (ORAL) 20MG QHS; CYCLOBENZAPRINE HCL (ORAL) 10MG PRN; MIRTAZAPINE (ORAL) 15MG QHS; OMEPRAZOLE (ORAL) QD. THE PATIENT'S MEDICAL HISTORY INCLUDES HYPERTENSION, STROKE, DIABETES TYPE 1, AND DIABETES TYPE 2. THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE-NO INJURY�ND THE EVENT WAS CONSIDERED RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630251 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Required Intervention