BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3362223 · Received September 23, 2013

    Report

    Report Number
    3004209178-2013-16737
    Event Type
    Injury
    Date Received
    September 23, 2013
    Date of Event
    September 4, 2013
    Report Date
    September 4, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT HAD SIGNS AND SYMPTOMS OF INFECTION. THE PATIENT EXPERIENCED SWELLING AT THE PUMP SITE, THE SITE WAS WARM TO TOUCH AND IT WAS RED AND ITCHY. THE PHYSICIAN DID NOT THINK IT WAS AN INFECTION. HE THOUGHT IT WAS JUST TOPICAL IRRITATION. WHEN THE PATIENT WENT IN FOR A CATHETER REVISION, THE POCKET WAS OPENED TO DISCONNECT THE CATHETER. THE POCKET ¿DID NOT LOOK RIGHT¿ TO THE DOCTOR; IT LOOKED IRRITATED. HE CULTURED THE POCKET AND SENT IT OFF FOR IN-DEPTH ANALYSIS. HE DECIDED TO REMOVE THE PUMP TO BE CAUTIOUS. THE REPORTER COULD NOT REMEMBER IF THE CATHETER WAS REMOVED AS WELL. THE PATIENT WAS GOING TO HAVE A NEW PUMP AND CATHETER PLACED ON (B)(6) 2013. THE CULTURE RESULTS WERE BELIEVED TO BE NEGATIVE. IT WAS LATER REPORTED THAT THE SURGERY WAS SCHEDULED FOR (B)(6) 2013. THE PATIENT WAS GOING TO GET A 40ML PUMP. IT WAS UNKNOWN IF THE PATIENT WOULD RECEIVE A NEW CATHETER. ALL INFORMATION REGARDING THIS EVENT WILL NOW BE REPORTED UNDER THIS MANUFACTURER REPORT #. PLEASE SEE MANUFACTURER REPORT #3004209 178-2013-16728 FOR ADDITIONAL PREVIOUSLY REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP POCKET WAS FOUND TO BE INFECTED DURING A CATHETER REVISION. THE PATIENT EXPERIENCED DRAINAGE/INCISIONAL WOUND OPENING AT THE DEVICE POCKET. THE HEALTHCARE PROVIDER (HCP) SENT TISSUE FOR LAB ANALYSIS, BUT THE ENTIRE SYSTEM WAS LEFT IN PLACE. THE INFECTION DISEASE DOCTOR WAS TO FOLLOW UP WITH THE PATIENT. THE PATIENT REQUIRED HOSPITALIZATION. THE PATIENT STATUS WAS REPORTED AS ¿ALIVE-NO INJURY¿. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. PLEASE SEE MANUFACTURER REPORT # 3004209178-2013-16728 FOR INFORMATION REGARDING THE CATHETER REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480166 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Other| R