BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1001780 · Received February 19, 2008

    Report

    Report Number
    6000030-2008-00804
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 1, 2006
    Report Date
    January 28, 2008
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE PT REPORTED, A LOSS OF THERAPEUTIC EFFECT SINCE PUMP REPLACEMENT IN 2006. THE PT ALSO REPORTED SEVERAL CATHETER REPLACEMENTS SINCE HER INITIAL CATHETER BROKE IN 2006 (SEE MFR'S REPORT #6000030200800803 FOR REPORT REGARDING INITIAL CATHETER BREAK). NO DATES WERE SPECIFIED FOR THE CATHETER REPLACEMENTS SINCE 2006 AND NO FURTHER DETAILS WERE PROVIDED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED; DEVICE REGISTRATION SYSTEM INDICATES MORPHINE. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK MEDTRONIC VASCULAR 8709 N076226021

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| PUMP MODEL UNK SERIAL# UNK| EXPLANTED:| IMPLANTED:| PROGRAMMER MODEL PROGRAMMER LOT# UNK| IMPLANTED: