BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2113749 · Received June 2, 2011

    Report

    Report Number
    3004209178-2011-03939
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    April 21, 2011
    Report Date
    May 5, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE PT EXPERIENCED A RETURN OF SYMPTOMS. THE SYMPTOMS WERE SEIZURES, VOMITING, AND A RETURN OF SPASTICITY. THIS RETURN OF SYMPTOMS BEGAN FOLLOWING AN MRI ON (B)(6) 2011. THE PT'S PUMP WAS CHECKED FOLLOWING THE MRI AND NO ISSUES WITH THE PUMP WERE NOTED. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM AT THE TIME OF THE EVENT WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other EXPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N254282| IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# N257329015