BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENIO IS

    MDR report key: 24691503 · Received March 25, 2026

    Report

    Report Number
    3017191859-2026-00011
    Event Type
    Injury
    Date Received
    March 25, 2026
    Date of Event
    February 20, 2026
    Report Date
    March 25, 2026
    Manufacturer
    ALFRIED KRUPP HOSPITAL
    Product Code
    MNQ
    PMA / PMN Number
    P240024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS PER A REVIEW OF AVAILABLE INFORMATION PROVIDED BY THE TREATING PHYSICIAN, NYXOAH CHIEF MEDICAL OFFICER HAS SUMMARIZED THE FOLLOWING: PATIENT HISTORY AND REPORT OF COMPLICATION: PATIENT WITH HISTORY OF OBSTRUCTIVE SLEEP APNEA WITH SIGNIFICANT MEDICAL HISTORY INCLUDING ATRIAL FIBRILLATION, CORONARY ARTERY DISEASE, HYPOTHYROIDISM, AORTIC ANEURYSM, HYPERCHOLESTEROLEMIA AND TOBACCO USE DISORDER. MEDICATIONS PRE AND POST SURGERY: ATORVASTATIN, RAMIPRIL, CALCITRIOL, LEVOTHYROXINE, EDOXABAN, RANOLAZIN, BISOPROLOL. BY REPORT, ON (B)(6) 2026 THE PATIENT UNDERWENT SUCCESSFUL IMPLANTATION OF GENIO. THE PROCEDURE WAS DESCRIBED AS UNEVENTFUL WITH NO UNEXPECTED BLEEDING OR INTRAOPERATIVE COMPLICATIONS. SEVERAL HOURS POSTOPERATIVELY, THE PATIENT EXPERIENCED SIGNIFICANT NECK SWELLING CONSISTENT WITH A RAPIDLY DEVELOPING HEMATOMA. THIS RESULTED IN AIRWAY COMPROMISE WITH INABILITY TO INTUBATE OR VENTILATE THE PATIENT. THE PATIENT REQUIRED EMERGENT TRACHEOTOMY TO ESTABLISH AN AIRWAY. HOWEVER, DURING THE TIME THAT WAS REQUIRED TO ESTABLISH THE AIRWAY AND VENTILATE THE PATIENT, THE PATIENT HAD A SIGNIFICANT PERIOD OF ANOXIA. WHILE HEMATOMA RESULTING IN AIRWAY COMPROMISE IS A KNOWN COMPLICATION OF NECK SURGERY, THE PATIENT'S COMORBIDITIES PUT THEM AT HIGH CARDIOVASCULAR RISK AND AT INCREASED BLEEDING RISK. CONTRIBUTING FACTORS: 1. CHRONIC ANTICOAGULATION THERAPY (RESIDUAL AT THE TIME OF SURGERY OR INDUCED BY RESTARTING ANTICOAGULATION POSTOPERATIVELY - THIS DETAIL OF RESTARTING MEDICATION IS STILL PENDING) REPRESENTS THE STRONGEST IDENTIFIABLE RISK FACTOR FOR THE HEMATOMA. 2. HYPERTENSION. IF BLOOD PRESSURE WAS ELEVATED POSTOPERATIVELY, THIS WOULD INCREASE RISK OF BLEEDING. 3. NICOTINE USE COULD CONTRIBUTE TO THE HEMATOMA BUT REPRESENTS A LESS LIKELY CAUSE IN ISOLATION. FURTHER, THE PATIENT'S CARDIOVASCULAR STATUS AND HISTORY MAY HAVE CONTRIBUTED TO REDUCED TOLERANCE OF HYPOXIA INDUCED BY AIRWAY COMPROMISE POTENTIALLY CONTRIBUTING TO ANOXIC BRAIN INJURY. SUMMARY: THE POSTOPERATIVE HEMATOMA RESULTING IN AIRWAY COMPROMISE IS A KNOWN COMPLICATION OF CERVICAL SURGICAL PROCEDURES. BASED ON REVIEW OF THE PATIENT'S COMORBIDITIES AND MEDICATION PROFILE, PARTICULARLY CHRONIC ANTICOAGULATION WITH EDOXABAN, THE EVENT IS MOST CONSISTENT WITH A PATIENT-RELATED BLEEDING COMPLICATION RATHER THAN DEVICE MALFUNCTION OR PROCEDURAL DEVIATION. AS PER THE DEVICE INVESTIGATION: THE DEVICE REMAINS IMPLANTED AND HENCE WILL NOT BE RETURNED FOR INVESTIGATION. A REVIEW OF MANUFACTURING RECORDS SHOWED NO ANOMALIES THAT OCCURRED DURING THE MANUFACTURING PROCESS THAT COULD HAVE LED TO THE REPORTED EVENT. A REVIEW OF THE TRAINING RECORDS INDICATES THE TREATING PHYSICIAN WAS APPROPRIATELY TRAINED AND PROCTORED ALLOWING THE PHYSICIAN TO PRACTICE GENIO IS IMPLANTS INDEPENDENTLY WITH A NUMBER OF SUCCESSFUL GENIO IS IMPLANTS. REVIEW OF CLINICAL LITERATURE: LIU J, SUN W, DONG W, WANG Z, ZHANG P, ZHANG T, ZHANG H. RISK FACTORS FOR POST-THYROIDECTOMY HAEMORRHAGE: A META-ANALYSIS. EUR J ENDOCRINOL. 2017 MAY;176(5):591-602. DOI: 10.1530/EJE-16-0757. EPUB 2017 FEB 8. PMID: 28179452. AND JEPPESEN K, MOOS C, HOLM T, PEDERSEN AK, SKJØT-ARKIL H. RISK OF HEMATOMA AFTER HEMITHYROIDECTOMY IN AN OUTPATIENT SETTING: A SYSTEMATIC REVIEW AND META-ANALYSIS. EUR ARCH OTORHINOLARYNGOL. 2022 AUG;279(8):3755-3767. DOI: 10.1007/S00405-022-07312-Y. EPUB 2022 MAR 16. PMID: 35294619; PMCID: PMC9249722. IT IS IMPORTANT TO NOTE THAT THERE IS NO AVAILABLE CLINICAL LITERATURE SURROUNDING HEMATOMA RELATED TO GENIO IS IMPLANTATION, HOWEVER THE CLINICAL LITERATURE DOES ADDRESS STATISTICS SURROUNDING HEMATOMA RATES RELATED TO VARIOUS NECK SURGERIES. THE RISK OF HEMATOMA REQUIRING EVACUATION IN ANTERIOR NECK SURGERY IS AS FOLLOWS: 1. HEMI-THYROIDECTOMY: RISK IS 0.5-1.1%. 2. TOTAL THYROIDECTOMY: BILATERAL SURGERY INCREASES RISK TO 1.5%. ADDITIONALLY, RISK OF HEMATOMA AFTER NECK DISSECTION DEPENDS ON THE EXTENT OF SURGERY: 1-3% OVERALL. SELECTIVE NECK DISSECTION 0.5-1.5%. MODIFIED RADICAL NECK: 2-4%. IN THE ABSENCE OF THE ACTUAL DEVICE FOR INVESTIGATION, THE RESULTS REMAIN INCONCLUSIVE, HOWEVER, BASED ON THE REVIEW OF THE PATIENT'S COMORBIDITIES AND MEDICATION PROFILE, PARTICULARLY CHRONIC ANTICOAGULATION WITH EDOXABAN, THE EVENT IS MOST CONSISTENT WITH A PATIENT-RELATED BLEEDING COMPLICATION RATHER THAN DEVICE MALFUNCTION OR PROCEDURAL DEVIATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT FILE WILL BE UPDATED AND A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    BY REPORT, ON (B)(6) 2026 THE PATIENT UNDERWENT SUCCESSFUL IMPLANTATION OF GENIO IMPLANTABLE STIMULATOR. THE PROCEDURE WAS DESCRIBED AS UNEVENTFUL WITH NO UNEXPECTED BLEEDING OR INTRAOPERATIVE COMPLICATIONS. SEVERAL HOURS POSTOPERATIVELY, THE PATIENT EXPERIENCED SIGNIFICANT NECK SWELLING CONSISTENT WITH A RAPIDLY DEVELOPING HEMATOMA. THIS RESULTED IN AIRWAY COMPROMISE WITH INABILITY TO INTUBATE OR VENTILATE THE PATIENT. THE PATIENT REQUIRED EMERGENT TRACHEOTOMY TO ESTABLISH AN AIRWAY. THE DEVICE REMAINS IMPLANTED. IT IS IMPORTANT TO NOTE THE IMPLANTABLE DEVICE IN THIS COMPLAINT FILE IS NOT DISTRIBUTED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747291 GENIO IS GENIO IS MNQ ALFRIED KRUPP HOSPITAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Life Threatening