BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1961077 · Received January 12, 2011

    Report

    Report Number
    3004209178-2011-00295
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    November 1, 2010
    Report Date
    January 6, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED WITHDRAWAL SYMPTOMS: INCREASED SPASTICITY, LEGS GET "JUMPY," AND SOME ITCHING. THE SYMPTOMS OCCURRED INTERMITTENTLY SINCE (B)(6) 2010. WHEN THE SYMPTOMS OCCURRED, THEY LASTED APPROXIMATELY 14 HOURS. THE PT CONTINUED TO EXPERIENCE THE SYMPTOMS DESPITE PUMP DRUG BOLUSES AND DOSING INCREASES. THERE WERE NO PUMP ALARMS. A DYE STUDY AND ROLLER STUDY REVEALED NO PROBLEMS. THE PHYSICIAN REQUESTED THE PUMP DRUG LIORESAL 2000 MCG/ML BE TESTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other IMPLANTED:| CATHETER: MODEL 8709, LOT #: L73611| EXPLANTED: