BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1000039 · Received February 15, 2008

    Report

    Report Number
    6000030-2008-00713
    Event Type
    Injury
    Date Received
    February 15, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 16, 2008
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTAL PORTION OF THE CATHETER WAS REMOVED AS THE PT EXPERIENCED LOSS OF BOWEL AND BLADDER CONTROL, LOSS OF FEELING IN ONE LEG AND WAS UNABLE TO MOVE HER LEGS. IT WAS NOT REPORTED IF ANY DEVICE TROUBLESHOOTING WAS PERFORMED. THE PUMP CONTAINED DILAUDID 1MG/ML WITH A DAILY DOSE OF 0.15MG AND BUPIVICAINE 10MG/ML WITH A DAILY DOSE OF 1.5MG. THE DRUG WAS TAKEN OUT OF THE PUMP AND REPLACED WITH PRESERVATIVE FREE NORMAL SALINE AND THE PUMP WAS PROGRAMMED TO MINIMUM RATE. THE REMAINING CATHETER WAS NOT ASPIRATED DURING THE REVISION. THE PT WAS LATER TAKEN TO RADIOLOGY TO HAVE THE CATHETER ACCESS PORT ASPIRATED TO REMOVE THE REMAINING DRUG FROM THE CATHETER. A PRIMING BOLUS WAS GIVEN TO REMOVE THE DRUG FROM THE PUMP TUBING. THE PT IS IN REHAB, BUT REPORTED THAT SHE WAS GETTING BACK TO NORMAL. THE PT WILL UNDERGO A REVISION OF THE DISTAL PORTION IN THE NEAR FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MFG 8731SC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R IMPLANTED| EXPLANTED| EXPLANTED| IMPLANTED| IMPLANTABLE INFUSION PUMP MODEL 8637| LOT # NGP313744H| PROGRAMMER MODEL 8840 LOT #UNK