BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1023479 · Received April 2, 2008

    Report

    Report Number
    6000030-2008-01735
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 3, 2008
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE PUMP REPLACEMENT, IT WAS NOTED THAT THE CATHETER ATTACHMENT TO THE PUMP WAS "CORRUPTED AT THE SUTURE TIE OF CATHETER ACCESS PORT" AND WAS DETERMINED TO BE BROKEN AND USEABLE. THE CATHETER WAS TRIMMED OF APPROX. 8 CM AND A PORTION OF A NEW PROXIMAL SECTION WAS ATTACHED TO THE NEW PUMP. CATHETER FLOW WAS NOTED TO BE EXCELLENT DURING THE REVISION; THE PT DID NOT EXHIBIT SIGNS OF WITHDRAWAL FROM THE HYDROMORPHONE 25 MG/ML BEING DELIVERED BY THE DRUG DELIVERY SYSTEM. THE DAILY DOSE WAS DECREASED BY APPROX ONE-THIRD BY THE HCP AND THE PT WAS HELD FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MFG 8703W L41567

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR EXPLANTED| PUMP MODEL #: 8627-18| IMPLANTED| PROGRAMMER MODEL LOT#UNK