BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 2873832 · Received December 14, 2012

    Report

    Report Number
    2182208-2012-04193
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    November 16, 2012
    Manufacturer
    RICE CREEK
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8709, LOT #: L82263, IMPLANTED: (B)(6) 2000, EXPLANTED: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS REMOVED BECAUSE IT WAS "LEAKING"; SPECIFIC LOCATION OF LEAK UNKNOWN TO THE REPORTER. IT WAS FURTHER ADDED THAT ABOUT 2-7DAYS POST EX-PLANT "A HOLE OPENED UP BY HER BELLY BUTTON AND BLOODY AND SEROUS FLUID FLOWED OUT." PUMP WAS INFUSING DILAUDID.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE DEVICE WAS REMOVED "AROUND 2002" BY A RETIRED PAIN DOCTOR. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention