BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1000041 · Received February 15, 2008

    Report

    Report Number
    6000030-2008-00719
    Event Type
    Injury
    Date Received
    February 15, 2008
    Report Date
    January 16, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED RINGING IN HER RIGHT EAR, POUNDING IN HER HEAD, LOSS OF THE MOTOR SKILLS IN HER LEFT ARM. SHE REPORTED THAT SHE CANNOT HOLD A CAN OF POP OR OPEN THE DOOR WITH A KNOB. SHE REPORTED HER LEFT ARM WAS A PURPLISH/REDDISH COLOR. SHE REPORTED THE BACK OF HER HEAD FELT STIFF AND VERY HEAVY ALL THE TIME; SHE CANNOT HOLD IT UP FOR VERY LONG TIME AND FELT A SHARP PAIN SHOOTING UP TO THE HEAD. THE HCP ORDERED A CT SCAN BUT HAS ALSO RECOMMENDED AN MRI TO RULE OUT A TUMOR OR MASS. PLEASE SEE MANUFACTURER'S REPORT #S: 6000030200800715 AND 6000030200800716.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8711 N086893032

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention IMPLANTED:| EXPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED:| IMPLANTABLE INFUSION PUMP MODEL 863720| IMPLANTED:| LOT# NGP301249H