BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3233735 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11957
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    May 17, 2013
    Report Date
    June 24, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8835 LOT# SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 8 709SC LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT EXPERIENCED INCREASED AND CONTINUED PAIN THAT WAS NOT CONTROLLED BY AN INCREASE IN MEDICATION. THE PATIENT WAS THEN ADMITTED TO THE HOSPITAL ON 2013 (B)(6) FOR SEVERE UNCONTROLLED PAIN. A CATHETER ACCESS PORT CONTRAST STUDY WAS PERFORMED WHICH REVEALED AN OCCLUDED CATHETER ON 2013 (B)(6). DURING SURGICAL OBSERVATION, AN OCCLUSION AT THE ANCHOR SITE WAS SEEN. THE CATHETER WAS REVISED ON 2013 (B)(6). THE PATIENT RESOLVED WITHOUT SEQUELAE ON 2013 (B)(6). THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE CATHETER WAS REVISED DUE TO A KINK AND MEDICINE WAS NOT FLOWING THROUGH THE CATHETER. THE PATIENT WAS GETTING THE PUMP REFILLED EVERY THREE MONTHS AND SOME OF THE MEDICATION WAS USED IN THE PUMP BUT IT WAS UNCLEAR WHERE IT WENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334340 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R