BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2061969 · Received April 5, 2011

    Report

    Report Number
    3004209178-2011-02580
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 23, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED WITHDRAWAL-LIKE SYMPTOMS SECONDARY TO AN UNSPECIFIED PUMP OR CATHETER MALFUNCTION. THE PATIENT EXPERIENCED INCREASED ANXIETY, DYSTONIA, SLEEPINESS, ITCHING, NAUSEA, DIZZINESS, AND AUDITORY AND VISUAL HALLUCINATIONS. THE PATIENT ALSO HAD AN INCREASED BLOOD PRESSURE. THE DEVICE SYSTEM WAS USED TO DELIVER COMPOUNDED BACLOFEN (2000 MCG/ML). ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR CATHETER: MODEL 8711, LOT# J10921R31| IMPLANTED:| EXPLANTED: