BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1030844 · Received April 17, 2008

    Report

    Report Number
    6000030-2008-02044
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    November 10, 2007
    Report Date
    March 19, 2007
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PIECES OF CATHETER WERE RETURNED FOR ANALYSIS; A SUTURELESS PUMP CONNECTOR AND 7.7 CM PROXIMAL PIECE TO THE PIN CONNECTOR PLUS A 49.4 CM PIECE, A 2.1 CM MIDDLE PIECE, AND A 25.2 CM PIECE TO THE DISTAL TIP. FINAL DEVICE ANALYSIS REVEALED A PUMP CONNECTOR ANOMALY. THE CONNECTOR WAS FUNCTIONALLY OK, AND ATTACHED SECURELY TO THE OUTLET PORT OF A PUMP, BUT THE RETAINING RING WAS SLIGHTLY DEFORMED IN SHAPE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A CONSTANT LEAK AND FLUID POCKET IN HIS BACK AND IN THE PUMP POCKET. THE HCP REVISED THE CATHETER AND ADDED A PURSE STRING SUTURE IN HIS BACK, BUT THE PT STATED HE WANTED THE PUMP OUT. THE DEVICE WAS EXPLANTED AND NOT REPLACED. THE HCP REPORTED THE PT OUTCOME AS 'NO INJURY, RECOVERED WITHOUT SEQUELA.' THE PUMP WAS USED TO DELIVER MORPHINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention EXPLANTED:| IMPLANTED:| PUMP MODEL # 863720| PROGRAMMER MODEL PROGRAMMER| EXPLANTED: