BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOMED

    MDR report key: 1080196 · Received July 22, 2008

    Report

    Report Number
    2182207-2008-04230
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 14, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P990034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER.

    Description of Event or Problem · 1

    AFTER IMPLANT, THE INTRATHECAL MORPHINE THERAPY WAS INITIALLY EFFECTIVE. AROUND THE FIRST OF MONTH, THE PT PRESENTED WITH SYMPTOMS OF UNDERINFUSION. THE HEALTH CARE PROFESSIONAL (HCP) FOUND MORE DRUG THAN EXPECTED IN THE RESERVOIR (3 MLS MORE THAN EXPECTED). THE HCP WAS UNABLE TO TEST CATHETER PATENCY WITH CONTRAST LIQUID BECAUSE IT WAS NOT POSSIBLE TO INJECT LIQUID FROM THE CATHETER ACCESS PORT. IN 2008, THE HCP DID A SURGICAL REVISION OF THE SYSTEM. AFTER DISCONNECTING THE CATHETER FROM THE PUMP, CATHETER PATENCY WAS VERIFIED; THE CATHETER APPEARED ACCESSIBLE. THE HCP CAREFULLY RECONNECTED THE CATHETER AND AFTER THIS RECONNECTION THE SYSTEM SEEMED TO BE FUNCTIONING PROPERLY; THE PUMP WAS NOW INFUSING AS EXPECTED AND THEREFORE NO SYSTEM COMPONENT WAS EXPLANTED. THERE WAS NO PT INJURY; THE PT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOMED LKK MEDTRONIC NEUROMODULATION 8472-20-05 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER MODEL 8731SC| EXPLANTED:| IMPLANTED: