BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 12053946 · Received June 23, 2021

    Report

    Report Number
    3004209178-2021-09868
    Event Type
    Injury
    Date Received
    June 23, 2021
    Date of Event
    May 19, 2021
    Report Date
    June 23, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169508149
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 PATIENT'S REPRESENTATIVE (CON) AND HEALTHCARE PROFESSIONAL (HCP) VIA A COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE INFUSION PUMP RECEIVING BACLOFEN AND MORPHINE BOTH WITH UNKNOWN CONCENTRATION AND DOSE. IT WAS REPORTED ON (B)(6) 2021 AT 9:34 AM HCP REPORTED THAT THE PATIENT WAS POSSIBLY WITHDRAWING FROM BACLOFEN. HCP STATED THAT PATIENT STARTED HALLUCINATING AFTER CONTRAST DYE LAST WEEK AND SYMPTOMS HAVE PROGRESSIVELY GOTTEN WORSE. HCP STATED THAT PUMP IS NOT ALARMING THAT THEY ARE AWARE OF. AT 13:31 ON (B)(6) 2021, PATIENT REP STATED THAT PATIENT WAS IN FLAGSTAFF MDC DUE TO AN ADVERSE REACTION TO A CATHETER DYE STUDY DONE ABOUT A WEEK AGO. CALLER WANTED REP TO BE PAGED AND AN EMAIL WAS SENT TO REP. IT WANS MENTIONED THAT PATIENT HAD A METAL TASTE, WEAKNESS, DIZZY AND CHILLS. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951260 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169508149

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other