BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3201472 · Received July 2, 2013

    Report

    Report Number
    3004209178-2012-12000
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    February 17, 2010
    Report Date
    January 20, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE PATIENT HAD UNSATISFACTORY SYMPTOM CONTROL SINCE IMPLANT. THE PATIENT EXPERIENCED FANTASTIC SYMPTOM CONTROL DURING THE TRIAL, BUT NONE SINCE THE IMPLANT. THE PATIENT WAS TAKING ORAL BACLOFEN TO MANAGE SYMPTOMS. THE PATIENT¿S WALKING ABILITY HAD WORSENED. THE PATIENT WAS ON MORPHINE AND BACLOFEN AFTER IMPLANT AND HAD AN 8 DAY STAY IN THE HOSPITAL BECAUSE OF AN ALLERGIC RESPONSE TO THE MORPHINE. THE PUMP WAS FLUSHED OUT, BUT THE PATIENT HAD ANOTHER REACTION THAT REQUIRED A 3 DAY HOSPITAL STAY. THE PATIENT WAS CONSIDERING HAVING THE PUMP OUT IF IT COULD NOT BE REFILLED AND ADJUSTED PROPERLY. 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
    303417 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR