BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 13190625 · Received January 7, 2022

    Report

    Report Number
    3004209178-2022-00281
    Event Type
    Injury
    Date Received
    January 7, 2022
    Date of Event
    July 14, 2021
    Report Date
    January 7, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169100831
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCTS: PRODUCT ID: 8709, LOT#: J11165R43, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: CATHETER. PRODUCT ID: 8575, LOT#: N140473, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8709, SERIAL/LOT #: (B)(4), UDI#: (B)(4); PRODUCT ID: 8575, SERIAL/LOT #: (B)(4), UBD: 08-FEB-2010, 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 HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT RECEIVING MORPHINE (15 MG/ML) VIA AN IMPLANTED PUMP. THE INDICATION FOR PUMP USE WAS SPINAL PAIN. THE HCP WAS CALLING FOR THE PUMP OFF PASSCODE. PER THE HCP, THERE WAS A REVISION/REPLACEMENT SCHEDULED. THE PATIENT HAD A FAILED SIDE PORT/DYE STUDY ABOUT 6 MONTHS AGO. THE PUMP OFF PASSCODE WAS GIVEN TO THE HCP DURING THE CALL ALONG WITH THE INSTRUCTIONS ON HOW TO PERMANENTLY SHUT DOWN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992920 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169100831

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention