BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 13366665 · Received January 27, 2022

    Report

    Report Number
    3004209178-2022-01268
    Event Type
    Malfunction
    Date Received
    January 27, 2022
    Date of Event
    January 26, 2022
    Report Date
    January 27, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169100831
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2015, EXPLANTED: (B)96) 2022, PRODUCT TYPE: CATHETER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8780, SERIAL/LOT #: (B)(4), UBD: 20-MAY-2017, 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 MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS RECEIVING DILAUDID (HYDROMORPHONE) (10 MG/ML AT .6MG/DAY) AND BUPIVACAINE (20 MG/ML AT 1.2 MG/DAY) VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT CAME IN TODAY FOR THEIR NORMAL PUMP REPLACEMENT DUE TO UPCOMING END OF SERVICE. THEIR CATHETER WAS FOUND TO HAVE NO FLOW SO IT WAS REPLACED.  THERE WERE NO KNOWN EXTERNAL FACTORS AND NO DIAGNOSTICS/TROUBLESHOOTING WERE PERFORMED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71324 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169100831

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male