BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202622 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-02830
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 11, 2012
    Report Date
    June 11, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8840, SERIAL# UNKNOWN; PRODUCT TYPE PROGRAMMER, PHYSICIAN PRODUCT ID 8709 LOT# J0058202R, IMPLANTED: 2001 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS EXPERIENCING SYMPTOMS OF INCREASED SPASTICITY. DOSAGE WAS BEING ADJUSTED TO ACCOMMODATE SYMPTOMS. THE DEVICE SYSTEM WAS USED TO DELIVER COMPOUNDED BACLOFEN. 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
    302613 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR