BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA CATHETER

    MDR report key: 1090763 · Received August 1, 2008

    Report

    Report Number
    6000030-2008-04600
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    November 3, 2006
    Report Date
    November 6, 2006
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SENT FOLLOWING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    PATIENT WAS BEING TREATED FOR BACK PAIN WITH MORPHINE (CONCENTRATION UNKNOWN) AT A DOSE OF 2MG/DAY DELIVERED USING AN INTRATHECAL CATHETER AND PUMP. PATIENT HAD BEEN ADMITTED TO THE ER WITH SYMPTOMS CONSISTENT WITH WITHDRAWAL. FIRST ONSET OF SYMPTOMS OCCURRED IN 2006. THE PATIENT WAS TREATED WITH IV MORPHINE AND DISCHARGED WITH ORAL MEDS. ADDITIONAL INFORMATION FROM A HCP (2007) INDICATED THE PUMP AND CATHETER HAD BEEN EVALUATED AND FOUND TO BE FUNCTIONING PROPERLY BASED ON A DYE STUDY AND RESERVOIR VOLUME CHECKS. THE PATIENT CONTINUED TO HAVE SYMPTOMS AND MULTIPLE ADMISSIONS FOR TREATMENT. BECAUSE THE PATIENTS SYMPTOMS COULD NOT BE CONTROLLED USING THE INTRATHECAL SYSTEM, HIS PHYSICIAN SCHEDULED SURGERY WITH PLANS TO REPLACE THE PUMP AND FURTHER INVESTIGATE THE CATHETER. THE PHYSICIAN NOTED THAT, DURING SURGERY TO REPLACE THE PUMP (ORIGINAL MONTH IN 2006), A PINHOLE LEAK WAS DISCOVERED IN THE CATHETER AND INDICATED IT WOULD CERTAINLY EXPLAIN THE PATIENT'S PROBLEMS. THE LEAK WAS REPAIRED. THE PATIENT RECOVERED WITHOUT SEQUELA. PUMP REPORTED UNDER REPORT 6000030200602152.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA CATHETER LKK RICE CREEK MANUFACTURING 8709 J10900R12

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R IMPLANTED:| EXPLANTED:| LOT# NGH016730R| IMPLANTABLE INFUSION PUMP MODEL 8627L18