BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3181593 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10681
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 22, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709 LOT# UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, IN (B)(6) 2012, THE PATIENT EXPERIENCED AN ADVERSE EVENT THAT WAS THE SAME AS THE ONE OCCURRING AT THE TIME OF REPORT, WHICH WAS SEVERE RESPIRATORY DEPRESSION AFTER A PUMP REFILL. IT WAS NOTED THAT THE ADMINISTRATION OF NALOXONE WAS NECESSITATED. THOUGH, AT THE TIME OF REPORT, THE PUMP CONTAINED FENTANYL, IT WAS UNCLEAR IF THE MEDICATION HAD CHANGED SINCE THE TIME OF THE EVENT.

    Description of Event or Problem · 1

    IT HAD ALSO BEEN REPORTED THAT, DURING THE EVENT OCCURRING AT THE TIME OF REPORT, THE RESPIRATORY DEPRESSION WAS A SYMPTOM OF AN OVERDOSE. IT WAS UNCLEAR IF THE ADVERSE EVENT THAT OCCURRED IN NOVEMBER 2012 WAS ALSO A SYMPTOM OF AN OVERDOSE. REFER TO MANUFACTURING REPORT #3004209178-2013-10287 FOR INFORMATION PERTAINING TO THE EVENT THAT WAS OCCURRING AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282857 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R