BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2093946 · Received May 16, 2011

    Report

    Report Number
    3004209178-2011-03536
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 22, 2011
    Manufacturer
    MDT 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 AN OVERDOSE OCCURRED ON (B)(6) 2011 AFTER A REFILL. THE PROCEDURE WAS THE CAUSE OF THE PROBLEM. THE PT WAS ACCIDENTALLY PROGRAMMED FOR A SINGLE BOLUS FOR THE TOTAL AMOUNT OF HER CONCENTRATION, 499 MCG/HR. THE PT'S DAILY DOSE WAS 105 MCG/DAY WITH A CONCENTRATION OF 500 MCG/ML. THE PT MADE IT OUT TO HER CAR, WHICH WAS PARKED IN THE PARKING LOT, AND THEN PASSED OUT FOR TEN HRS. THE PT WOKE UP AT 4 AM AND URINATED ON HERSELF. THE PT THEN WENT IN AND OUT OF CONSCIOUSNESS FOR A COUPLE HRS AND THEN DROVE HERSELF HOME. THE PT DID NOT CONTACT ANYONE UNTIL THE NEXT WEEK. THE PT WAS SEEN BY THE PHYSICIAN FOLLOWING THE EVENT. NO REPROGRAMMING WAS REQUIRED. IT WAS NOT KNOWN HOW THE PT WAS DOING. THE DRUGS THAT WERE IN THE PUMP AT THE TIME OF THE EVENT WAS REPORTED AS FENTANYL AND LIORESAL. ADDITIONAL INFO HAS BEEN REQUESTED; A F/U REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention CATHETER: MODEL 8731SC, LOT# N108346030| IMPLANTED:| EXPLANTED: