BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2874996 · Received December 17, 2012

    Report

    Report Number
    3007566237-2012-03030
    Event Type
    Injury
    Date Received
    December 17, 2012
    Report Date
    November 17, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT # J0058118R, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2012. ON (B)(6) 2012, THE NURSE REPORTED AN OVERDOSE. THE PATIENT HAD INCREASED LETHARGY DURING THE DAY TO THE POINT WHERE BY THAT NIGHT THE PATIENT WAS PUT ON A NARCAN DRIP AND WAS WAKING UP. THE HCP DID NOT KNOW WHAT DRUG WAS IN THE PUMP. THE PATIENT WAS IN THE ICU. THEY WERE CONSIDERING STOPPING THE PUMP, BUT DECIDED TO WAIT UNTIL MORNING AND KEEP THE PATIENT ON A NARCAN DRIP THROUGH THE NIGHT. THE PATIENT WAS BEING SEEN BY A PHYSICIAN IN THE MORNING. THE NURSE DIDN'T BELIEVE THAT THE PUMP WAS FILLED ON (B)(6) 2012. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R