BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3941748 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-13181
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    June 26, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED "SHORTLY" AFTER IMPLANT, THE PATIENT EXPERIENCED "TREATMENT LAPSES" AS A RESULT OF THE PUMP'S FAILURE. IT WAS BELIEVED THE PUMP CAUSED THE PATIENT "CONSIDERABLE HARM" AND PERSONAL INJURIES. THE PUMP WAS USED TO DELIVER BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419677 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR