BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1960948 · Received January 11, 2011

    Report

    Report Number
    3004209178-2011-00276
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS IN THE ER WITH VOMITING, DIARRHEA, AND LOW BLOOD PRESSURE. IT WAS UNK IF THE PT HAD A PUMP REFILL RECENTLY. THE HEALTHCARE PROVIDER WAS SUSPECTING AN OVERDOSE. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT IF ADD'L 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 71 YR Other EXPLANTED:| IMPLANTED:| CATHETER: MODEL #8709SC, LOT# N169255010