BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2914234 · Received January 14, 2013

    Report

    Report Number
    3004209178-2013-00557
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    December 19, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1060-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_CATH, SERIAL # UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POSSIBLE POCKET FILL OCCURRED DURING A REFILL PROCEDURE ON (B)(6) 2012. THE DOCTOR ATTEMPTED TO REFILL THE PATIENT PUMP AND AFTER INJECTING 10ML OF THE MEDICATION SHE WAS ONLY ABLE TO ASPIRATE 9ML BACK, INDICATING A POTENTIAL POCKET FILL OF 1ML. IT WAS NOTED THAT THE DOCTOR FOLLOWED THE USUAL PROTOCOLS FOR REFILLING THE PUMP. AS OF THE DATE OF THE REPORT THERE WERE NO APPARENT UNTOWARD SEQUELAE FROM THE EVENT. THE PATIENT APPEARED TO BE DOING WELL AND DID NOT REQUIRE ANY SPECIALIZED MEDICAL ATTENTION AS A RESULT OF THE EVENT. THE PATIENT'S PUMP WAS FUNCTIONING AS NORMAL. THE PATIENT WAS TO BE FOLLOWED FOR THE NEXT SEVERAL DAYS FOLLOWING THE EVENT, BUT NO ADVERSE EVENTS WERE ANTICIPATED. THE PATIENT WAS TO BE SEEN AT THE NEXT REFILL APPOINTMENT. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21713 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Other