BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4913625 · Received July 14, 2015

    Report

    Report Number
    3004209178-2015-13367
    Event Type
    Injury
    Date Received
    July 14, 2015
    Date of Event
    June 19, 2015
    Report Date
    June 22, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8709, LOT# J0178003R, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: CATHETER. PRODUCT ID: 8575, LOT# N101822, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN ENCEPHALOPATHIC FOR 3 DAYS PRIOR TO THE REPORT. IT WAS BELIEVED THAT THE PATIENT DID NOT HAVE AN INFECTION. MOST LIKELY, THE PATIENT¿S RATE WAS INCREASED TOO QUICKLY. THE PATIENT WAS HOSPITALIZED AND CONTINUED TO BE UNRESPONSIVE. THE CHANGES IN THERAPY/SYMPTOMS WERE CONSIDERED TO BE SUDDEN. THE PUMP WAS INFUSING BACLOFEN (UNKNOWN) AND MORPHINE (UNKNOWN). NO INTERVENTIONS OR OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF MORE INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455034 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization