BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3143477 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08577
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    January 30, 2013
    Report Date
    May 15, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS BEING REMOVED THE SAME DAY AS REPORT WAS MADE, IT WAS NOT REPORTED IF THE DEVICE WAS TO BE RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 6 MONTHS PRIOR TO THE REPORT A COMPLETE POCKET FILL OF 20ML OCCURRED DURING PUMP REFILL. PER THE PATIENT¿S HEALTHCARE PROVIDER (HCP), THE PATIENT DID NOT HAVE ANY ISSUES. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL. IT WAS LATER REPORTED THAT THE POCKET FILL OCCURRED ON 2013 (B)(6). THE PATIENT HAD NO SYMPTOMS WITH THE CONFIRMED 20ML POCKET FILL. THE PATIENT WAS MONITORED BUT HAD NO SYMPTOMS OF OVERDOSE. THE PUMP WAS APPROPRIATELY FILLED AND THERAPY RESUMED. IT WAS ALSO NOTED THAT THE PATIENT FULLY RECOVERED FOLLOWING THE POCKET FILL.

    Description of Event or Problem · 1

    THE PREVIOUSLY REPORTED INFORMATION ¿ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS BEING REMOVED THE SAME DAY AS REPORT WAS MADE, IT WAS NOT REPORTED IF THE DEVICE WAS TO BE RETURNED TO THE MANUFACTURER¿ WAS REPORTED IN MANUFACTURER REPORT # 3004209 178-2013-08590 AND DOES NOT PERTAIN TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243675 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00012 YR Other