BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1230560 · Received November 13, 2008

    Report

    Report Number
    3004209178-2008-07451
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 15, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-2380-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: USED FOR THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS "NOT GETTING THE FULL EFFECT AND NOT GETTING FULL RELIEF". THE HCP PERFORMED AN MRI AND DETERMINED THAT THERE WAS A LEAKAGE IN THE CATHETER. THE PT STATED THAT THE "CATHETER WAS BROKEN IN HALF". THE CATHETER WAS REPLACED IN 2008. IT WAS ALSO REPORTED THAT THE PT WAS "CURRENTLY DOING FINE SINCE REPLACEMENT". THE CONCENTRATION AND DAILY DOSE OF BACLOFEN BEING DELIVERED VIA THE PUMP WAS NOT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC| PROGRAMMER: MODEL 8840