BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 12522856 · Received September 23, 2021

    Report

    Report Number
    2182207-2021-01643
    Event Type
    Injury
    Date Received
    September 23, 2021
    Date of Event
    May 18, 2021
    Report Date
    September 23, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID :NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ORSAGH-YENTIS, D. K., RYAN, K., HURWITZ, N., DIEFENBACH, K. A., TEICH, S., MOUSA, H., BALI, N., VAZ, K., YACOB, D., LORENZO, C. D., LU, P. L. GASTRIC ELECTRICAL STIMULATION IMPROVES SYMPTOMS AND NEED FOR SUPPLEMENTAL NUTRITION IN CHILDREN WITH SEVERE NAUSEA AND VOMITING: A TEN-YEAR EXPERIENCE. NEUROGASTROENTEROL MOTIL. 2021. E14199 DOI: 10.1111/NMO.14199 SUMMARY: GASTRIC ELECTRICAL STIMULATION (GES) IS A PROMISING THERAPY FOR CHILDREN WITH SEVERE NAUSEA AND VOMITING, BUT INFORMATION ON LONG-TERM OUTCOMES IS LIMITED. WE SOUGHT TO EVALUATE THE LONG-TERM EFFICACY AND SAFETY OF GES AND TO DESCRIBE PATIENT BENEFIT AND SATISFACTION. USING A PROSPECTIVE REGISTRY, WE IDENTIFIED PATIENTS AGED 21 YEARS TREATED WITH GES AT OUR INSTITUTION BETWEEN 2009 AND 2019. ENCOUNTERS WERE SELECTED AT BASELINE PRIOR TO GES AND AT FOLLOW-UP AT 1 MONTH, 12 MONTHS, AND THE MOST RECENT VISIT. WE COMPARED SYMPTOMS, ROUTE OF NUTRITION, AND MEDICATION USAGE AT BASELINE TO FOLLOW-UP TIMEPOINTS. FACTORS ASSOCIATED WITH IMPROVEMENT WERE EVALUATED. WE RECORDED COMPLICATIONS AND NEED FOR BATTERY REPLACEMENT. WE CONTACTED FAMILIES TO ADMINISTER THE GLASGOW CHILDREN'S BENEFIT INVENTORY (GCBI) AND A PARENT SATISFACTION QUESTIONNAIRE. EIGHTY-FIVE PATIENTS (68.2% FEMALE, MEDIAN AGE 15.8 YEARS) COMPLETED A TRIAL OF TEMPORARY GES DUE TO SEVERE NAUSEA AND VOMITING. SEVENTY-SEVEN (90.6%) HAD A POSITIVE RESPONSE AND UNDERWENT PERMANENT STIMULATOR PLACEMENT. USE OF TUBE FEEDING OR PARENTERAL NUTRITION (PN) DECREASED FROM 72.7% AT BASELINE TO 29.9% AT THE MOST RECENT FOLLOW-UP (P <(><<)> 0.001). HIGHER BASELINE VOMITING SEVERITY WAS ASSOCIATED WITH THE ABILITY TO STOP SUPPLEMENTAL NUTRITION BY 1 MONTH (P <(><<)> 0.05). FOURTEEN PATIENTS (18.2%) HAD COMPLICATIONS, PRIMARILY DUE TO STIMULATOR-ASSOCIATED DISCOMFORT, AND 29 (37.7%) REQUIRED BATTERY REPLACEMENT. MEDIAN GCBI WAS +52.1, INDICATING HEALTH-RELATED BENEFIT. CHILDREN WITH SEVERE NAUSEA AND VOMITING TREATED WITH GES EXPERIENCED SIGNIFICANT AND DURABLE IMPROVEMENT IN SYMPTOM SEVERITY AND THEIR ABILITY TO TOLERATE ORAL NUTRITION. REPORTED EVENTS: FOURTEEN PATIENTS (18.2%) HAD COMPLICATIONS THAT NECESSITATED FURTHER SURGERY. THE MOST COMMON REASONS FOR SURGERY WERE PATIENTS¿ EXPERIENCING AN UNCOMFORTABLE SHOCKING SENSATION OR FEELING THAT THE GES WAS MOVING OR MALFUNCTIONING IN SOME REGARD. OF NOTE, THE ELECTRODES OF ONE PATIENT (WHOSE STIMULATOR HAD BEEN PLACED AT AN OUTSIDE FACILITY) ERODED THROUGH THE GASTRIC WALL. THAT PATIENT'S STIMULATOR WAS REMOVED AND THEN PERMANENTLY REPLACED AT OUR INSTITUTION. NO SPECIFIC DEVICE INFORMATION PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416222 IMPLANTABLE NEUROSTIMULATOR INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention