BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1895474 · Received November 5, 2010

    Report

    Report Number
    6000030-2010-08970
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    March 11, 2004
    Report Date
    October 15, 2010
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "PUMP INFECTED" NO "LONG" AFTER IMPLANT. THE PUMP WAS REMOVED. THE PT WAS IN THE HOSPITAL FOR "ABOUT"A WEEK AND THEN HAD A DEVICE INSTALLED IN HER NECK WITH IV MEDICATION ADMINISTERED AT HOME FOR ABOUT 8 WEEKS. THE PUMP WAS REINSTALLED "LATER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention LOT# NGV005350N| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J12035R17| EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J11530R29| IMPLANTED:| CATHETER: MODEL 8731, LOT# B005840N06| IMPLANTABLE INFUSION PUMP: MODEL 863740| IMPLANTED: