BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOMED

    MDR report key: 2700360 · Received August 15, 2012

    Report

    Report Number
    3007566237-2012-01976
    Event Type
    Malfunction
    Date Received
    August 15, 2012
    Report Date
    July 20, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: CATHETER. PRODUCT ID: 861718, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999, PRODUCT TYPE: PUMP. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. THE MEDICATION USED WAS INFUMORPH (MORPHINE) 6MG/ML AT 3MG/DAY. THE PATIENT OUTCOME WAS REPORTED AS NO INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: IT WAS NOTED THE PUMP WAS HELPING THE PATIENT A FEW YEARS BACK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE PATIENT STATED THAT "THAT THE PUMP IS NOT WORKING AND IS NOT PROVIDING PAIN RELIEF", AND IF IT WAS PROVIDING RELIEF THAT IT WAS "VERY LITTLE." FOR THE "LAST FEW MONTHS" UP TO REPORT DATE, THE PATIENT HAD DIFFICULTY WALKING AND CONTROLLING HIS BALANCE. THE PATIENT FELL ABOUT 6 TIMES, AND THEN STARTED USING A WALKER. IT WAS BELIEVED BY THE HEALTHCARE PROVIDER (HCP) THAT THE FALLS OCCURRED "BECAUSE OF THE BACK" PROBLEMS. THE PATIENT HAD A CT SCAN WHICH SHOWED STENOSIS OF THE LUMBAR SPINE. THE PATIENT WAS SUPPOSED TO HAVE A CT MYELOGRAM WITH DYE, HOWEVER THE PATIENT "COULD NOT TAKE THE PAIN FOR THE CT MYELOGRAM BECAUSE THEY WERE RUNNING INTO SO MUCH SCAR TISSUE," SO THEY "STOPPED THE TEST." NO OTHER DIAGNOSTIC TESTING HAD BEEN COMPLETED ON THE PUMP SYSTEM. THE HCP SUGGESTED INCREASING THE PUMP DOSAGE WHEN THE PATIENT COMPLAINED OF NO PAIN RELIEF; HOWEVER, THE REPORTER STATED THAT THE PATIENT HAD "TROUBLE STAYING AWAKE BECAUSE OF THE DRUG PUMP." THE PATIENT HAS NO OTHER PRESCRIBED ORAL PAIN MEDICATIONS. THE MEDICATION IN THE PUMP WAS MORPHINE. IT WAS LATER REPORTED, IN REGARDS TO THE DEVICE OR THERAPY, THAT THE PUMP "HASN'T BEEN INSTALLED YET, MAYBE AUGUST 9TH." IT WAS UNCLEAR WHETHER OR NOT A PUMP REPLACEMENT WAS PLANNED FOR AUGUST 9TH. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8472-35-05

    Patients

    Seq Age Sex Outcome Treatment
    1