BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 11806311 · Received May 11, 2021

    Report

    Report Number
    3004209178-2021-07526
    Event Type
    Injury
    Date Received
    May 11, 2021
    Report Date
    May 11, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169630505
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    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 BY A COMPANY REPRESENTATIVE (REP) FROM A HEALTHCARE PROVIDER (HCP) ABOUT A PATIENT RECEIVING DILAUDID (HYD ROMORPHONE), 2.5 MG/ML FOR CONCENTRATION, 0.4599 MG/DAY FOR DOSE, AND BUPIVACAINE (CONCENTRATION OF 4.5 MG/ML AND 0.8279 MG/DAY FOR DOSE) VIA IMPLANTABLE PUMP. IT WAS REPORTED THAT PATIENT REPORTED A REDNESS AND WARMTH AT PUMP SITE THAT WOULD CLEAR UP WITH ORAL ANTIBIOTICS BUT RETURNED WHEN THE DOSE IS FINISHED. INTERVENTIONS/ACTIONS THAT WERE TAKEN TO RESOLVE THE ISSUE WAS THE REPLACEMENT OF THE PUMP AND CATHETER AT A NEW SITE DUE TO SUSPECTED INFECTION. IT WAS REPORTED THAT THE EXISTING LEFT ABDOMEN PUMP AND CATHETER WERE EXPLANTED ON (B)(6) 2021. A NEW PUMP AND CATHETER WERE IMPLANTED TO THE RIGHT SIDE OF THE ABDOMEN. NO DIAGNOSTICS/TROUBLESHOOTING WERE PERFORMED, NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. IT WAS MENTIONED THAT IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. IT WAS REPORTED THAT THE PATIENT MEDICAL HISTORY WAS CERVICAL CANCER AND RADIATION COLITIS. PATIENT WEIGHT WAS ASKED BUT UNKNOWN. PATIENT STATUS AT TIME OF THIS REPORT WAS ALIVE - NO INJURY. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704491 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169630505

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention