BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 12561249 · Received October 1, 2021

    Report

    Report Number
    3004209178-2021-14685
    Event Type
    Injury
    Date Received
    October 1, 2021
    Date of Event
    September 27, 2021
    Report Date
    October 1, 2021
    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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8596SC, SERIAL#: (B)(4) IMPLANTED: (B)(6) 2021, PRODUCT TYPE: CATHETER. PRODUCT ID: 8590-1, LOT#: N060037, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8731, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2021, PRODUCT TYPE: CATHETER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER VIA A DEVICE MANUFACTURER REPRESENTATIVE REGARDING A PATIENT RECEIVING BACLOFEN VIA AN IMPLANTABLE INFUSION PUMP. IT WAS REPORTED THAT THE PUMP SITE WAS INFECTED AND THE SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457919 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00763000422608

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention