BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2830061 · Received November 13, 2012

    Report

    Report Number
    3004209178-2012-10194
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709SC SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. HCP REPORTED THE EVENT WAS UNRELATED TO THE PUMP. ANOTHER TREATING PHYSICIAN HAS STARTED THE PATIENT ON FENTANYL PATCH, WHEN THE PATCH WAS REMOVED THE SYMPTOMS WERE RESOLVED. THERE WAS NO DIFFICULTY WITH THE PUMP. PATIENT RECOVERED WITHOUT SEQUELAE. DRUG IN THE PUMP REPORTED AS COMPOUND MORPHINE/BUPIVACAINE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IN THE EMERGENCY ROOM (ER) DUE TO HAVING "TOO MUCH NARCOTIC ON BOARD" AND THE PUMP DOSE NEEDED TO BE ADJUSTED DOWN OR STOPPED. THE ER HEALTHCARE PROVIDER (HCP) WAS GOING TO CONTACT THE PUMP MANAGEMENT HCP. NO ADDITIONAL INFORMATION WAS PROVIDED. MEDICATION IN THE PUMP WAS MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention