BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1801168 · Received August 11, 2010

    Report

    Report Number
    3004209178-2010-06036
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 13, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    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 PT WAS UNRESPONSIVE AFTER A REVISION AND THE HCP WANTED TO STOP THE PUMP. PT WAS PREVIOUSLY AT 1600 MCG/DAY AND THE CONCENTRATION OF FENTANYL WAS 5000 MCG/ML.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT # L58353