BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3012348 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-03952
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    September 11, 2012
    Report Date
    May 17, 2016
    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, 8731SC SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: 2012-09-11 EXPLANTED: 2012-09-18 PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PUMP AND CATHETER WERE REMOVED DUE TO INFECTION. THE NEXT DAY, IT WAS REPORTED THAT THERE WERE NO KNOWN DETAILS OF THE PATIENT'S SYMPTOMS, LOCATION OF THE INFECTION, OR IF A CULTURE WAS TAKEN. AT THE TIME OF REPORT, THE PATIENT WAS DOING WELL AND WAS RECEIVING EFFECTIVE THERAPY. THE DRUG USED IN THIS SYSTEM WAS MORPHINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER. PER THE PATIENT, THE PUMP FAILED WITHIN A WEEK OF BEING IMPLANTED ON (B)(6) 2012 BECAUSE HIS BODY REJECTED IT DUE TO INFECTION. THE PATIENT HAD THE PUMP EXPLANTED ON (B)(6) 2012. AT THE TIME OF THE EVENT THE PUMP HAD DELIVERED INTRATHECAL BACLOFEN AND MORPHINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT¿S PUMP MOVED AND ¿FAILED¿ AFTER IMPLANT. IT CREATED A CAVITY THAT FILLED UP WITH BLOOD. IT WAS REPORTEDLY NOT AN INFECTION, BUT THE DEVICE WAS REMOVED DUE TO THE EVENT. IT WAS STATED THAT THE PATIENT¿S STOMACH AREA SWELLED UP LIKE A GRAPEFRUIT, THOUGH IT WAS UNCLEAR IF THIS TOOK PLACE PRIOR TO OR AFTER THE EXPLANT. THE NEXT TIME A PUMP WAS IMPLANTED, IT WAS NOTED THAT THE¿ATTACHMENTS WERE BETTER SOMEHOW¿ AND THERE HAD BEEN RESTRUCTURING WITH THE WHOLE PUMP ITSELF ON HOW IT WAS ATTACHED. IT WAS UNCLEAR IF THE REPORTER WAS TALKING ABOUT HIS SPECIFIC PUMP OR PUMPS IN GENERAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116045 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention