BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 15155532 · Received August 3, 2022

    Report

    Report Number
    3004209178-2022-09802
    Event Type
    Injury
    Date Received
    August 3, 2022
    Date of Event
    July 26, 2022
    Report Date
    August 3, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00763000422608
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2022, PRODUCT TYPE: CATHETER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8780, SERIAL/LOT #: (B)(4), UBD: 17-MAR-2024, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING LIORESAL (BACLOFEN) (500MCG/ML AT 119MCG) VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY. IT WAS REPORTED THAT PATIENT HAD A SWELLING IN THE LOWER BACK NEAR INCISION IMPLANT. THEY BELIEVED IT WAS FROM AN OLD PUNCTURE ATTEMPT AT TIME OF IMPLANT. THE PROVIDER OPENED  THE BACK AND THE CATHETER WAS INTACT BUT THEY WERE UNABLE TO DO A DYE STUDY. CALLER STATED THEY NOTICED A PREVIOUS LUMBAR PUNCTURE SITE WAS LEAKING CEREBRA SPINAL FLUID (CSF) THE DOCTOR PUT A PURSE STRING SUTURE TOO THIS SITE. THE ISSUE WAS RESOLVED, PATIENT ALIVE NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1903737 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00763000422608

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male Required Intervention