BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 5726874 · Received June 15, 2016

    Report

    Report Number
    3007566237-2016-02279
    Event Type
    Injury
    Date Received
    June 15, 2016
    Date of Event
    November 24, 2015
    Report Date
    June 15, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT AGE: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. CONCOMITANT MEDICAL PRODUCTS: OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3387, , PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SAYEGH, R.R., SWEET, J.A., MILLER, J.P., HAYEK SM. ELECTRICAL STIMULATION OF THE TRIGEMINAL GANGLION AND INTRATHECAL DRUG DELIVERY S YSTEMS FOR THE MANAGEMENT OF CORNEAL NEUROPATHIC PAIN. CORNEA. 2016. 35(4):576-577. SUMMARY: CORNEAL NEUROPATHIC PAIN MANIFESTS AS SEVERE DRY EYE¿LIKE SYMPTOMS WITH HYPERALGESIA, PHOTOALLODYNIA, AND BLEPHAROSPASM, A SSOCIATED WITH MINIMAL OCULAR SURFACE FINDINGS. THE PAIN IS ONLY PARTIALLY RELIEVED WITH TOPICAL CORNEAL ANESTHESIA OR USE OF A SCLERAL LENS, AND THE PHOTOALLODYNIA TYPICALLY DOES NOT RESPOND TO CYCLOPLEGIA. CORNEAL NEUROPATHIC PAIN CAN BE SEEN AFTER CORNEAL NERVE INJURY AS A SIDE EFFECT OF LASER IN SITU KERATOMILEUSIS (LASIK), AND ONSET IS OFTEN DELAYED DAYS TO YEARS AFTER THE PROCEDURE. THESE SYMPTOMS RARELY RESPOND TO TRADITIONAL DRY EYE THERAPY OR SYSTEMIC THERAPY. WE REPORT A CASE OF CORNEAL NEUROPATHIC PAIN RESISTANT TO BOTH OCULAR AND SYSTEMIC THERAPIES THAT WAS SUCCESSFULLY MANAGED SURGICALLY USING ELECTRICAL STIMULATION OF THE TRIGEMINAL GANGLION AND IMPLANTATION OF A HIGH CERVICAL INTRATHECAL INFUSION SYSTEM. REPORTED EVENTS: A FEMALE PATIENT WHO RECEIVED AN ELECTRODE TARGETING THE TRIGEMINAL GANGLION TO TREAT CORNEAL NEUROPATHIC PAIN EXPERIENCED IMMEDIATE RELIEF OF THEIR PAIN AFTER IMPLANT, AND THIS PERSISTED UNTIL AT LEAST 8 MONTHS AFTER THE PROCEDURE, AT WHICH POINT THEIR THERAPEUTIC PARESTHESIAS DISAPPEARED AND THEIR OCULAR PAIN SYMPTOMS RETURNED. X-RAY IMAGING SHOWED THAT THE LEAD HAD MIGRATED ANTERIORLY. THE LEAD WAS REPLACED WITH A ¿LONGER ELECTRODE¿ BUT IT WAS NOT POSSIBLE TO CONTROL THE PATIENT¿S SYMPTOMS SO THE PATIENT ULTIMATELY REQUESTED THAT THE ENTIRE SYSTEM BE EXPLANTED. TWO MONTHS AFTER THE STIMULATOR WAS EXPLANTED THE PATIENT WAS SUCCESSFULLY TRIALED WITH AND RECEIVED AN INTRATHECAL INFUSION PUMP, WHICH AFFORDED THE PATIENT CONSISTENT PAIN RELIEF UP TO THE TIME OF PUBLICATION. NOTE THAT THE AUTHORS ALTERNATELY REPORTED THE PATIENT¿S AGE AS (B)(6) IN THE ABSTRACT, AND (B)(6) IN THE BODY OF THE ARTICLE; FOLLOW-UP WITH THE CORRESPONDING AUTHOR HAS BEEN REQUESTED TO CLARIFY THIS INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381490 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37712 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention