BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 983209 · Received January 15, 2008

    Report

    Report Number
    6000030-2008-00255
    Event Type
    Injury
    Date Received
    January 15, 2008
    Date of Event
    October 1, 2007
    Report Date
    October 29, 2007
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP CONNECTOR (WITHOUT THE CONNECTOR END PIECE) AND 17.5 CM OF PROXIMAL TUBING WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS REVEALED THE CONNECTOR WAS BROKEN AROUND THE SUTURE RING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2007, THE PATIENT FELL IN THE BATH ONTO HER RIGHT SIDE. IT WAS REPORTED BY THE PATIENT'S HUSBAND THAT THE PUMP "EXPLODED." THE PATIENT WAS HOSPITALIZED. SHE HAD COGNITIVE AND OVERDOSE SYMPTOMS, AND THERE WAS A LARGE SWELLING NOTED AT THE PUMP SITE WHICH WAS A SUSPECTED INFECTION OR CEREBROSPINAL FLUID LEAK. THE DEVICE WAS EXPLANTED TWO MONTHS LATER, AND A CRACK WAS SEEN AT THE JOINT OF THE PUMP AND CATHETER. THE HCP REPORTED THAT THERE WAS NO INJURY TO THE PATIENT. THE PUMP WAS USED TO DELIVER DILAUDID 40 MG/ML AND BUPIVACAINE 10 MG/ML. PLEASE SEE MFR REPORT # 2152207-2007-04151.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8703 J93111859

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R IMPLANTED| EXPLANTED| PUMP MODEL # 8703| EXPLANTED| PROGRAMMER MODEL 8840 LOT# UNK| IMPLANTED