BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE INFUSION PUMP

    MDR report key: 5353353 · Received January 8, 2016

    Report

    Report Number
    3007566237-2016-00127
    Event Type
    Malfunction
    Date Received
    January 8, 2016
    Report Date
    December 12, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    SHAH, G., ING, J. GADOLLNIUM ENCEPHALOPATHY AFTER CATHETER DYE STUDY (10652). NORTH AMERICAN NEUROMODULATION SOCIETY 19TH ANNUAL MEETING. 2015. 42. SUMMARY: INTRATHECAL PUMPS ARE AN EFFECTIVE TOOL TO TREAT MULTIPLE CAUSES OF PAIN RANGING FROM CHRONIC INTRACTABLE PAIN, CANCER PAIN TO SPASTICITY. INTRATHECAL PUMPS ALLOW DIRECT DELIVERY OF MEDICATIONS INTO THE INTRATHECAL SPACE, ALLOWING FOR MINIMIZATION OF CERTAIN SIDE EFFECTS AND REDUCING DOSE REQUIREMENTS OF CERTAIN MEDICATIONS. THERE HAVE BEEN SEVERAL NOTED POTENTIAL COMPLICATIONS OF INTRATHECAL CATHETERS WHICH INCLUDE CATHETER KINK, BREAK OR EVEN DISCONNECTS. IN AN ATTEMPT TO IDENTIFY SOME OF THESE POTENTIAL COMPLICATIONS A CATHETER DYE STUDY MAY BE DONE. THIS CASE HIGHLIGHTS A POTENTIAL COMPLICATION FROM A CATHETER DYE STUDY. REPORTED EVENTS: THE PATIENT IS A (B)(6) FEMALE WHO PRESENTED FOR INTRATHECAL DYE STUDY. SHE HAD THE PUMP PLACED IN 2009 FOR CHRONIC PAIN FROM POST-LAMINECTOMY SURGERY SYNDROME. DUE TO SUSPECTED PUMP MALFUNCTION, SHE WAS SCHEDULED FOR CATHETER DYE STUDY. OF NOTE, BECAUSE OF AN ALLERGY TO SHELLFISH, IODINE BASED SOLUTION COULD NOT BE USED IN THE DYE STUDY. THUS, OMNISCAN WAS SELECTED TO EVALUATE THE CATHETER. A TOTAL OF 1 CC WAS INJECTED INTO THE ACCESSORY PORT AND VISUALIZED GOING THROUGH THE CATHETER INTO THE INTRATHECAL SPACE APPROPRIATELY. AFTER THIS WAS COMPLETED THE PUMP WAS REPROGRAMMED AND A PRIMING BOLUS WAS GIVEN. APPROXIMATELY 12 HOURS AFTER STUDY SHE PRESENTED TO THE EMERGENCY DEPARTMENT WITH GENERALIZED TONIC-CLONIC SEIZURES. AT THIS TIME, THE PATIENT HAD CT SCAN DONE WHICH DEMONSTRATED EXTENSIVE HYPERDENSITY WITHIN THE SUBARACHNOID SPACE AND BASAL CISTERNS. THE HYPERDENSITY RESOLVED AFTER 2 DAYS PER IMAGING RESULTS. THIS WAS BELIEVED TO BE MOST LIKELY DUE TO GADOLINIUM ENCEPHALOPATHY. PATIENT HAD A LONG RECOVERY IN THE HOSPITAL REQUIRING INTUBATION AND WAS EVENTUALLY DISCHARGED ABOUT 45 DAYS AFTER ADMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13680 IMPLANTABLE INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR