BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 5010347 · Received August 18, 2015

    Report

    Report Number
    3007566237-2015-02298
    Event Type
    Injury
    Date Received
    August 18, 2015
    Report Date
    July 20, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_PUMP, PRODUCT TYPE: PUMP. PRODUCT ID: NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER. (B)(4)

    Description of Event or Problem · 1

    CARAWAY, D., WALKER, V., BECKER, L., HINNENTHAL, J. SUCCESSFUL DISCONTINUATION OF SYSTEMIC OPIOIDS AFTER IMPLANTATION OF AN INTRATHECAL DRUG DELIVERY SYSTEM. NEUROMODULATION : JOURNAL OF THE INTERNATIONAL NEUROMODULATION SOCIETY. 2015. DOI: 10.1111/NER.12318. SUMMARY: AN IMPLANTABLE DRUG DELIVERY SYSTEM (IDDS) PROVIDES AN ALTERNATE ROUTE OF OPIOID ADMINISTRATION FOR PATIENTS WITH CHRONIC PAIN. WE COLLECTED DATA ON SYSTEMIC OPIOID USE BEFORE AND AFTER IDDS IMPLANTATION; PATIENTS WHO SUCCESSFULLY DISCONTINUED SYSTEMIC OPIOIDS; AND PHYSICIAN SUPPORT OF DISCONTINUATION. THIS WAS A SINGLE-CENTER, RETROSPECTIVE CHART REVIEW OF 99 CONSECUTIVE PATIENTS WHO USED IDDSS FOR AT LEAST SIX MONTHS. DATA COLLECTION INCLUDED PRE/POSTIMPLANT SYSTEMIC OPIOID USE AND PAIN SCORES, AND PATIENT DEMOGRAPHIC AND CLINICAL CHARACTERISTICS. THE STUDY POPULATION AVERAGED 67 YEARS OF AGE, WAS 68% WOMEN, AND 77% WERE MEDICARE BENEFICIARIES. NINETY-FIVE PERCENT OF PATIENTS HAD LOWBACK PAIN, AND 86% HAD LIMB PAIN. THE MAJORITY (81%) HAD PAIN FOR >5 YEARS. FAILED TREATMENTS INCLUDED EPIDURAL INJECTIONS (74%), LUMBAR SPINE SURGERY (46%), SPINAL CORD STIMULATION (14%), AND FACET JOINT INJECTIONS (11%), WITH 84% ALSO REPORTING SIGNIFICANT SYSTEMIC OPIOID SIDE-EFFECTS. ALL PATIENTS TAKING LONG-ACTING OPIOIDS DISCONTINUED THESE WITHIN ONE MONTH OF IMPLANT. TOTAL SYSTEMIC OPIOID ELIMINATION WAS ACCOMPLISHED BY 68% OF PATIENTS AT ONE MONTH POSTIMPLANT, 84% AT ONE YEAR, AND 92% AT FIVE YEARS. AT ONE MONTH POSTIMPLANT, 60% OF PATIENTS REPORTED DECREASED PAIN (MEAN CHANGE: -4.07), AND AT ONE YEAR, 64% DID (MEAN CHANGE: -3.42). IDDS CAN PROVIDE SIGNIFICANT AND LASTING PAIN RELIEF AND AN ALTERNATE ROUTE OF DELIVERY COMPARED WITH SYSTEMIC OPIOIDS WITH THEIR ASSOCIATED SIDE-EFFECTS. WE DEMONSTRATED THAT SYSTEMIC OPIOID ELIMINATION COULD BE ACCOMPLISHED AFTER IDDS IMPLANTATION IN THE MAJORITY OF CASES THROUGH APPROPRIATE PATIENT SELECTION, MONITORING, AND PARTICIPATION. REPORTED EVENTS: ONE INTRATHECAL DRUG DELIVERY SYSTEM WAS REMOVED AFTER FOURTEEN DAYS DUE TO INFECTION. THE SYSTEM WAS NOT REPLACED FOR FIFTEEN MONTHS. FOUR INTRATHECAL DRUG DELIVERY SYSTEMS WERE REPLACED DUE TO REASONS OTHER THAN END OF BATTERY LIFE. NONE OF THE REPLACEMENTS RESULTED FROM DEVICE/MECHANICAL FAILURES. ONE PATIENT HAD AN EXPLANT PROCEDURE DUE TO THERAPY FAILURE. TEN PATIENTS HAD CATHETER REVISIONS, AND MOST WERE ATTRIBUTABLE TO CATHETER-SPECIFIC PROBLEMS, SUCH AS KINKING OR FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544086 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention