BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1051687 · Received May 21, 2008

    Report

    Report Number
    2182207-2008-02707
    Event Type
    Injury
    Date Received
    May 21, 2008
    Report Date
    April 21, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER RELATED TO THIS EVENT WAS NOT IDENTIFIED. PER THE MANUFACTURER'S DEVICE TRACKING SYSTEM, THIS PT HAD TWO CATHETERS ACTIVE AT THE TIME OF THE EVENT. WE WERE UNABLE TO DETERMINE WHICH CATHETER WAS THE CATHETER RELATED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD AN INFLAMMATORY MASS. IT WAS DESCRIBED AS SCAR TISSUE ON THE DISTAL END OF THE CATHETER. THE ISSUE WAS ADDRESSED BY THE MANAGING HCP. NO PT SYMPTOMS WERE REPORTED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, 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 NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PUMP MODEL 863720 LOT# NGP301325H| EXPLANTED:| EXPLANTED:| PROGRAMMER MODEL 8840| IMPLANTED:| IMPLANTED:| CATHETER MODEL 8709SC| IMPLANTED:| EXPLANTED:| CATHETER MODEL 8709SC