BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3022782 · Received March 27, 2013

    Report

    Report Number
    3004209178-2013-04279
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 2, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PUMP AND CATHETER WERE REPLACED DUE TO AN INFECTION, SEVERAL MONTHS PRIOR TO REPORT. FOUR DAYS LATER, IT WAS REPORTED THAT THE PUMP HAD "REALLY HELPED TO CONTROL HER PAIN." THE PATIENT'S SYMPTOMS WERE UNKNOWN, ALONG WITH WHETHER A CULTURE WAS TAKEN. THE DRUG USED IN THIS SYSTEM WAS UNKNOWN, THOUGH IT WAS NOTED THAT THERE WAS NO BACLOFEN IN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126212 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention