BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 7021981 · Received November 10, 2017

    Report

    Report Number
    3004209178-2017-23558
    Event Type
    Injury
    Date Received
    November 10, 2017
    Date of Event
    January 1, 2017
    Report Date
    November 10, 2017
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE DEVICE SYSTEM; THE OTHER RELEVANT COMPONENTS INCLUDE: PRODUCT ID: 8781, SERIAL (B)(4), IMPLANTED: (B)(6) 2015, EXPLANTED: (B)(6) 2017, 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 A CONSUMER VIA A MANUFACTURER REPRESENTATIVE WITH AN IMPLANTABLE DRUG INFUSION PUMP INDICATED FOR INTRACTABLE SPASTICITY. THE PUMP CONTAINED AN UNKNOWN BRAND OF BACLOFEN WITH AN UNKNOWN CONCENTRATION AND DOSE. IT WAS REPORTED CATHETER DYE STUDY WAS DONE IN 2017, AND THEY WERE UNABLE TO ASPIRATE. THE PATIENT WENT TO THE SURGEON AND HAD THEIR PUMP AND CATHETER REPLACED. NO PATIENT SYMPTOMS WERE REPORTED. THE REPRESENTATIVE ALSO STATED IT WAS ODD THAT THEY REPLACED THE PUMP, BUT HAD NO IDEA WHY THAT WOULD HAVE BEEN DONE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798428 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169100831

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention