BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHOMED II

    MDR report key: 2201768 · Received August 5, 2011

    Report

    Report Number
    3004209178-2011-06117
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN OVERDOSE. THE PATIENT HAD DECREASED RESPONSIVENESS. THE EVENT OCCURRED FOLLOWING A REFILL. THE PUMP WAS PROGRAMMED TO THE MINIMUM RATE AND NO NARCAN WAS GIVEN. THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHOMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization CATHETER: MODEL 8709SC, LOT# N150430012| IMPLANTED:| EXPLANTED: