BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4102694 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17392
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1150-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED AFTER THE PATIENTS¿ MRI THE PUMP ACTIVATED ITSELF WITHIN 2 HOURS. PER THE PATIENT THEY WANTED TO CHECK TO SEE IF THERE WAS ANY BUILD-UP OF MEDICATION AT THE INJECTION SITE. THE MRI CAME OUT ¿FINE¿. THE PUMP WAS USED TO DELIVER CLONIDINE AND DILAUDID.

    Description of Event or Problem · 1

    THE PATIENT WAS HAVING AN MRI TO RULE OUT A GRANULOMA. THE PATIENT SYMPTOMS, ACTIONS TAKEN, OUTCOME, AND DRUG IN THE PUMP WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584168 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Other