BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1012470 · Received March 12, 2008

    Report

    Report Number
    6000030-2008-01207
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    September 22, 2006
    Report Date
    October 5, 2006
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    THE HCP REPORTED THE PT WAS EXPERIENCING DECREASED EFFICACY OF THE NARCOTICS - MORPHINE, BUPIVACAINE, AND CLONIDINE (UNK CONCENTRATION/DOSE). IT WAS ALSO NOTED THAT THERE WAS INCREASED PRESSURE WHEN ACCESSING THE REFILL PORT. A ROLLER ARM STUDY SHOWED THE ROLLER ARM DID NOT MOVE. THE CATHETER WAS DETERMINED TO BE KINKED. THE PT UNDERWENT A CATHETER REVISION AND PUMP REPLACEMENT. THE OUTCOME WAS REPORTED AS "FULL FUNCTIONING INTRATHECAL DRUG DELIVERY SYSTEM IN PLACE. PT DISCHARGED PER HOSPITAL PROTOCOL." ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK MEDTRONIC VASCULAR 8731 B011500N35

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R IMPLANTABLE INFUSION PUMP: MODEL 8627L18| IMPLANTED:| IMPLANTED: UNK| EXPLANTED: UNK| PROGRAMMER: MODEL PROGRAMMER LOT# UNKNOWN| EXPLANTED: