BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1001687 · Received February 15, 2008

    Report

    Report Number
    6000030-2008-00698
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    April 1, 2007
    Report Date
    January 15, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE HCP REPORTED THAT THE PATIENT HAD INCREASED PAIN. ON (B)(6) 2007 MORE MEDICATION WAS REMOVED FROM THE PUMP THAN ANTICIPATED; THE PUMP WAS INTERROGATED ON (B)(6) 2007. THE HCP WAS UNABLE TO ASPIRATE FLUID FROM THE CATHETER PORT DUE TO A KINK/OCCLUSION IN THE SUBCUTANEOUS SECTION OF THE CATHETER; THERAPY WAS ABANDONED. ON (B)(6) 2007 THE CATHETER WAS SURGICALLY CUT PROXIMAL TO THE KINKS IN THE ABDOMINAL SITE. THE HCP WAS UNABLE TO FIND THE REST OF THE CATHETER IN THE LUMBAR REGION. THAT PART OF THE CATHETER WAS RETAINED, BUT WAS NOT SPLICED TO THE NEW CATHETER. THE PATIENT WAS RESTARTED ON MORPHINE 1 MG/ML AT 0.4998 MG/DAY ON (B)(6) 2008 AND WAS REPORTED TO HAVE RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8709 N092772003

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention EXPLANTED:| IMPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK| IMPLANTABLE INFUSION PUMP MODEL 863720| IMPLANTED:| EXPLANTED| LOT# NGP303714H