BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1002563 · Received February 8, 2008

    Report

    Report Number
    2182207-2008-00599
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    January 8, 2008
    Report Date
    January 8, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A PUMP REPLACEMENT DUE TO ANTICIPATED END OF PUMP LIFE, AND DURING THE PROCEDURE, THEY WERE UNABLE TO ASPIRATE THE CATHETER. THE CATHETER WAS NOT IN THE INTRATHECAL SPACE AS NOTED ON A CT SCAN PERFORMED PRIOR TO THE SURGERY. THE HCP FELT THAT SINCE THE PT WAS GETTING GOOD SYMPTOM CONTROL NO INTERVENTION WAS NEEDED WITH THE CATHETER. THE PUMP WAS NOT PRIMED DURING SURGERY, BUT WAS STARTED WHEN THE PT WAS IN PACU. THE PT DID NOT HAVE ANY ADVERSE SYMPTOMS RELATED TO THIS. PT IS RECEIVING LIORESAL, BUT IT IS UNK WHAT THE CONCENTRATION OR DOSAGE WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK MEDTRONIC NEUROMODULATION CATHETER UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R IMPLANTABLE INFUSION PUMP MODEL 8637 LOT# UNK| EXPLANTED| IMPLANTED