BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3864262 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11306
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THE PATIENT RECENTLY HAD A CATHETER REVISION {REFER TO MANUFACTURER REPORT # 3004209178-2014-10215} AND WAS GETTING GOOD THERAPY, BUT NOW WAS NOT. A DYE STUDY WAS PERFORMED AND THE HEALTHCARE PROVIDER (HCP) SAW DYE IN THE PATIENT¿S POCKET WHERE THE PUMP IS. IT WAS NOTED THE HCP WAS CONCERNED ABOUT A CATHETER DISCONNECT. A ROLLER STUDY WAS GOING TO BE PERFORMED ON (B)(6) 2014. IT WAS ALSO REPORTED THERE WERE NO STALLS WHEN THE PUMP WAS INTERROGATED. THE PUMP WAS BEING USED TO DELIVER GABLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338204 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1