BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 8415197 · Received March 12, 2019

    Report

    Report Number
    3007566237-2019-00597
    Event Type
    Injury
    Date Received
    March 12, 2019
    Date of Event
    January 1, 2008
    Report Date
    March 12, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: ISLAM S, VICK LR, RUNNELS MJ, GOSCHE JR, ABELL T. GASTRIC ELECTRICAL STIMULATION FOR CHILDREN WITH INTRACTABLE NAUSEA AND GASTROPARESIS. JOURNAL OF PEDIATRIC SURGERY. 2008. 43, 437-442. DOI: 10.1016/J.JPEDSURG.2007.10.005. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE SEX OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THIS DATE IS BASED OFF OF THE ARTICLE¿S PUBLICATION DATE AS THE SPECIFIC EVENT DATE WAS NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENTS WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: ASKU, UDI#: ASKU. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    LITERATURE SUMMARY: GASTRIC ELECTRICAL STIMULATION (GES) HAS BEEN PERFORMED IN ADULTS AS A TREATMENT OF REFRACTORY NAUSEA AND VOMITING IN PATIENTS WHO HAVE FAILED MEDICAL TREATMENT, BUT HAS NOT BEEN USED IN CHILDREN. NINE PATIENTS WITH CHRONIC NAUSEA AND VOMITING WITH A MEAN AGE OF 14 YEARS WERE EVALUATED FOR TEMPORARY GES. ALL 9 PATIENTS SUBSEQUENTLY UNDERWENT PLACEMENT OF A TEMPORARY FOLLOWED BY PERMANENT GES DEVICE. SYMPTOMS WERE RECORDED AT BASELINE, AFTER TEMPORARY GES, AND THEN AFTER PERMANENT GES USING A LIKERT SCALE FOR GASTROPARESIS. STATISTICAL ANALYSIS WAS PERFORMED USING A PAIRED STUDENT'S T TEST. THE AUTHORS CONCLUDED THAT GES CAN BE SUCCESSFULLY APPLIED TO ADOLESCENTS WITH INTRACTABLE NAUSEA AND GASTROPARESIS SYMPTOMS WHO FAIL MEDICAL THERAPY. THERE IS A SIGNIFICANT IMPROVEMENT IN SYMPTOMS OVER A PROLONGED PERIOD, AND THERE ARE NO ADVERSE EFFECTS OF THE GES. LONG-TERM EFFICACY OF THIS THERAPY IN CHILDREN NEEDS TO BE ESTABLISHED. REPORTED EVENTS: IT WAS REPORTED A (B)(6) YEAR-OLD FEMALE PATIENT (PATIENT 9) EXPERIENCED A POCKET INFECTION WITH EROSION OF THE SKIN OVER THE POCKET TWO YEARS AFTER IMPLANT. IT WAS NOTED THE PATIENT HAD TRAUMA TO THE AREA, WHICH CAUSED THE EROSION. THE PATIENT¿S DEVICE WAS EXPLANTED AS A RESULT OF THE ISSUE; THE PATIENT EXPERIENCED A RECURRENCE OF SYMPTOMS AFTER REMOVAL OF THE STIMULATOR AND WAS BEING EVALUATED FOR REIMPLANTATION AT THE TIME OF THE ARTICLE. THE PATIENT WAS NOTED TO HAVE HAD A MEDICAL HISTORY OF POSTSURGICAL GASTROPARESIS WITH SYMPTOMS OF PAIN, NAUSEA, BLOATING, AND WEIGHT LOSS. IT WAS REPORTED A (B)(6) YEAR-OLD FEMALE PATIENT (PATIENT 8) WHO INITIALLY RESPONDED TO THEIR THERAPY EXPERIENCED RECURRENT SYMPTOMS THAT RESULTED IN THEIR IMPLANTABLE NEUROSTIMULATOR (INS) BEING REPLACED. IT WAS FURTHER REPORTED THE PATIENT¿S THERAPEUTIC RESPONSE FAILED WITHIN 2 TO 4 MONTHS OF IMPLANT. IT WAS NOTED THE PATIENT HAD GASTROSTOMY AND JEJUNOSTOMY TUBES PLACED FOR LONG-TERM FEEDING BECAUSE BIOPSIES REVEALED THE ABSENCE OF THE INTERSTITIAL CELLS OF CAJAL IN THE STOMACH AND SMALL BOWEL, AT WHICH POINT THE STIMULATOR WAS REMOVED. IT WAS NOTED THE PATIENT WAS FOUND TO HAVE HAD ¿A COMPLETE ABSENCE OF THE CAJAL CELLS IN THE STOMACH AND SMALL BOWEL.¿ SHE REQUIRED 2 LAPAROTOMIES FOR COMPLICATIONS OF THE JEJUNAL TUBE. THE PATIENT WAS NOTED TO HAVE HAD A MEDICAL HISTORY OF IDIOPATHIC/POSTVIRAL GASTROPARESIS WITH SYMPTOMS OF PAIN, NAUSEA, VOMITING, AND WEIGHT LOSS. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208275 IMPLANTABLE NEUROSTIMULATOR INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention