BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    KEEOGO - CLINICIAN KIT

    MDR report key: 23086519 · Received September 18, 2025

    Report

    Report Number
    3011819880-2025-12200
    Event Type
    Injury
    Date Received
    September 18, 2025
    Date of Event
    September 8, 2025
    Report Date
    February 10, 2026
    Manufacturer
    B-TEMIA INC
    Product Code
    PHL
    UDI-DI
    07540162060007
    PMA / PMN Number
    K201539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE KEEOGO DERMOSKELETON INVOLVED IN THIS EVENT WAS INSPECTED ON SITE BY THE CLINICAL TEAM AND CONFIRMED TO BE FUNCTIONING PROPERLY BEFORE, DURING, AND AFTER THE INCIDENT. NO DEVICE MALFUNCTION, DEFECT, OR ABNORMAL BEHAVIOR WAS IDENTIFIED. THE ADVERSE EVENT WAS REPORTED TO THE FRENCH COMPETENT AUTHORITY (ANSM) ON 2025-09-18 BY THE MANUFACTURER (B-TEMIA) IN ACCORDANCE WITH EU MDR REQUIREMENTS. AT THIS STAGE, NO REMEDIAL ACTION OR FIELD SAFETY CORRECTIVE ACTION WAS INITIATED. THE PATIENT REMAINS HOSPITALIZED IN STABLE CONDITION. B-TEMIA WILL SUBMIT A SUPPLEMENTAL MDR ONCE ADDITIONAL CLINICAL INFORMATION BECOMES AVAILABLE FROM THE INVESTIGATIONAL SITE (E.G., PATIENT CARDIOVASCULAR HISTORY, CONCOMITANT MEDICATIONS, BASELINE VITAL SIGNS)

    Additional Manufacturer Narrative · 0

    THE KEEOGO DERMOSKELETON INVOLVED IN THIS EVENT WAS INSPECTED ON SITE BY THE CLINICAL TEAM AND CONFIRMED TO BE FUNCTIONING PROPERLY BEFORE, DURING, AND AFTER THE INCIDENT. NO DEVICE MALFUNCTION, DEFECT, OR ABNORMAL BEHAVIOR WAS IDENTIFIED. THE ADVERSE EVENT WAS REPORTED TO THE FRENCH COMPETENT AUTHORITY (ANSM) ON 2025-09-18 BY THE MANUFACTURER (B-TEMIA) IN ACCORDANCE WITH EU MDR REQUIREMENTS. AT THIS STAGE, NO REMEDIAL ACTION OR FIELD SAFETY CORRECTIVE ACTION WAS INITIATED. THE PATIENT REMAINS HOSPITALIZED IN STABLE CONDITION. B-TEMIA WILL SUBMIT A SUPPLEMENTAL MDR ONCE ADDITIONAL CLINICAL INFORMATION BECOMES AVAILABLE FROM THE INVESTIGATIONAL SITE (E.G., PATIENT CARDIOVASCULAR HISTORY, CONCOMITANT MEDICATIONS, BASELINE VITAL SIGNS). FOLLOW-UP INFORMATION: THE ADVERSE EVENT WAS ALSO REPORTED TO THE ANSM ON 2025-09-05 BY THE SPONSOR. THE EVENT WAS DECLARED TO THE MANUFACTURER ON 2025-09-08 (FU1). THE PATIENT UNDERWENT TWO CORONARY ANGIOPLASTY PROCEDURES WITH STENT IMPLANTATION ON (B)(6) 2025 (SECOND MARGINAL ARTERY) AND (B)(6) 2025 (MID RIGHT CORONARY ARTERY). HE WAS DISCHARGED HOME ON (B)(6) 2025 WITH APPROPRIATE CARDIOVASCULAR PHARMACOTHERAPY. THE RESEARCH PROCEDURE WAS DEFINITIVELY DISCONTINUED. THE SUBJECT WAS WITHDRAWN FROM THE STUDY (FU1). THE INVESTIGATOR AND THE SPONSOR ASSESSED THE RELATIONSHIP WITH THE RESEARCH PROCEDURES AS PROBABLE. THE INVESTIGATOR ASSESSED THE RELATIONSHIP WITH THE INVESTIGATIONAL DEVICE AS PROBABLE. THE SPONSOR ASSESSED THE RELATIONSHIP WITH THE DEVICE AS WITHOUT RELATION. PEAK TROPONIN REACHED 342 NG/L. A MAJOR DYSLIPIDEMIA WAS IDENTIFIED (LDL CHOLESTEROL 2.43 G/L) (FU1). ON (B)(6) 2025, THE PATIENT WAS REASSESSED BY THE PRINCIPAL INVESTIGATOR. CLINICAL STATUS REMAINED UNCHANGED SINCE DISCHARGE. THE SUBJECT WAS NOT YET RECOVERED. CLINICAL EVOLUTION WAS ASSESSED AS IMPROVEMENT (FU2). ON (B)(6) 2025, CLINICAL STATUS REMAINED UNCHANGED. A CARDIOPULMONARY EXERCISE TEST ((B)(6) 2025) REVEALED A MILD ALTERATION OF AEROBIC CAPACITY, PREDOMINANTLY PERIPHERAL, WITH NO CARDIOLOGICAL RISK CRITERIA. PROGRESSIVE RESUMPTION OF ACTIVITIES WAS CONSIDERED POSSIBLE. A REHABILITATION AND EXERCISE RECONDITIONING PROGRAM WAS PLANNED FOR LATE (B)(6) 2025. THE SUBJECT WAS NOT YET RECOVERED AS OF (B)(6) 2025. CLINICAL EVOLUTION WAS ASSESSED AS IMPROVEMENT (FU3). THE PATIENT UNDERWENT AN INPATIENT REHABILITATION AND EXERCISE RECONDITIONING PROGRAM FROM (B)(6) 2025 TO (B)(6) 2025, INCLUDING GAIT RETRAINING. THE EVENT WAS ASSESSED AS RESOLVED ON (B)(6) 2025, WITH SEQUELAE CONSISTING OF A CORONARY STENT. HOSPITALIZATION PERIODS: (B)(6) 2025 TO (B)(6) 2025 (CARDIOLOGY DEPARTMENT), (B)(6) 2025 TO (B)(6) 2025 (REHABILITATION AND EXERCISE RECONDITIONING). WALKING TESTS WERE PERFORMED ON (B)(6) 2026. THE RELATIONSHIP ASSESSMENTS WITH THE RESEARCH PROCEDURES (PROBABLE PER INVESTIGATOR AND SPONSOR) AND WITH THE DEVICE (PROBABLE PER INVESTIGATOR, WITHOUT RELATION PER SPONSOR) REMAIN UNCHANGED (FU4). AT THIS STAGE, NO REMEDIAL ACTION OR FIELD SAFETY CORRECTIVE ACTION HAS BEEN INITIATED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, DURING THE EXHOMESEP CLINICAL INVESTIGATION IN FRANCE (PROTOCOL ID-(B)(4)), A 74-YEAR-OLD MALE SUBJECT (PATIENT ID: (B)(6) WITH A PRE-EXISTING DIAGNOSIS OF PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS EXPERIENCED ACUTE CARDIAC SYMPTOMS WHILE PERFORMING A SUPERVISED REHABILITATION EXERCISE SESSION WITH THE KEEOGO DERMOSKELETON SYSTEM. AT 15:00, THE SUBJECT DEVELOPED RETROSTERNAL CONSTRICTIVE CHEST PAIN RADIATING TO THE JAW AND LEFT ARM DURING THE SESSION. SYMPTOMS RESOLVED AFTER STOPPING THE EXERCISE. AT 20:00, CHEST PAIN RECURRED AT REST FOR ABOUT ONE HOUR, WITH BLOOD PRESSURE MEASURED AT 180 MMHG. ECG WAS INCONCLUSIVE. TROPONIN LATER TESTED POSITIVE (INCREASE FROM 10 NG/L TO 35 NG/L). ON (B)(6) 2025 AT 02:00, CHEST PAIN RECURRED AGAIN, REQUIRING ADMISSION TO THE CARDIOLOGY DEPARTMENT FOR SUSPECTED ANGINA/NSTEMI. THE EVENT WAS CLASSIFIED AS LIFE-THREATENING. THE PATIENT REMAINED HOSPITALIZED IN STABLE CONDITION AT THE TIME OF REPORTING. THE KEEOGO DEVICE WAS INSPECTED BY THE STUDY TEAM AND CONFIRMED TO BE FUNCTIONING PROPERLY BEFORE, DURING, AND AFTER THE INCIDENT, WITH NO DEFECT OR MALFUNCTION IDENTIFIED. THE INVESTIGATOR NOTED THE POSSIBILITY THAT THE PHYSICAL EFFORT REQUIRED WHILE USING THE DEVICE DURING EXERCISE MAY HAVE CONTRIBUTED TO THE EVENT. ECG: T WAVE INVERSION IN LEAD T AND AVL; SLIGHT ST DEPRESSION IN V4-V5. BIOLOGICAL RESULTS: POTASSIUM 3.5 MMOL/L; CREATININE 68 [?]MOL/L; EGFR 90 ML/MIN; TROPONIN 12 NG/L THEN 35 NG/L; WBC 6 G/L; HEMOGLOBIN 14.5 G/DL; PLATELETS 220 G/L. ECHOCARDIOGRAPHY: SEVERE HYPOKINESIA OF THE MID-TO-DISTAL INFEROLATERAL WALL, EXTENDING LATERALLY; FINDINGS COMPATIBLE WITH MYOCARDIAL ISCHEMIA. CLINICAL ASSESSMENT: CARDIOPULMONARY EXAM WITHOUT SIGNS OF HEART FAILURE. DATE OF CARDIOLOGY ADMISSION: (B)(6) 2025. PRE-EXISTING CONDITION: PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS (PPMS). NO KNOWN CARDIOVASCULAR HISTORY PRIOR TO THE EVENT. RISK FACTORS: AGE, MALE SEX, SEDENTARY LIFESTYLE, HISTORY OF SMOKING CESSATION, FAMILY HISTORY (FATHER HAD MYOCARDIAL INFARCTION BEFORE AGE 50). NO CONCOMITANT MEDICATIONS REPORTED. CONCOMITANT THERAPY: SUPERVISED PHYSICAL REHABILITATION IN CENTER (STARTED (B)(6) 2025).

    Description of Event or Problem · 0

    ON (B)(6) 2025, DURING THE EXHOMESEP CLINICAL INVESTIGATION IN FRANCE (PROTOCOL ID-(B)(4), A 74-YEAR-OLD MALE SUBJECT (PATIENT ID: (B)(6)) WITH A PRE-EXISTING DIAGNOSIS OF PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS EXPERIENCED ACUTE CARDIAC SYMPTOMS WHILE PERFORMING A SUPERVISED REHABILITATION EXERCISE SESSION WITH THE KEEOGO DERMOSKELETON SYSTEM. AT 15:00, THE SUBJECT DEVELOPED RETROSTERNAL CONSTRICTIVE CHEST PAIN RADIATING TO THE JAW AND LEFT ARM DURING THE SESSION. SYMPTOMS RESOLVED AFTER STOPPING THE EXERCISE. AT 20:00, CHEST PAIN RECURRED AT REST FOR ABOUT ONE HOUR, WITH BLOOD PRESSURE MEASURED AT 180 MMHG. ECG WAS INCONCLUSIVE. TROPONIN LATER TESTED POSITIVE (INCREASE FROM 10 NG/L TO 35 NG/L). ON (B)(6) 2025 AT 02:00, CHEST PAIN RECURRED AGAIN, REQUIRING ADMISSION TO THE CARDIOLOGY DEPARTMENT FOR SUSPECTED ANGINA/NSTEMI. THE EVENT WAS CLASSIFIED AS LIFE-THREATENING. ON (B)(6) 2025, AN ACUTE SUB-OCCLUSIVE STENOSIS AT THE OSTIUM OF THE SECOND MARGINAL ARTERY WAS IDENTIFIED AND TREATED BY ANGIOPLASTY WITH STENT IMPLANTATION (FU1). ON (B)(6) 2025, A SECOND ANGIOPLASTY WAS PERFORMED WITH STENT IMPLANTATION IN THE MID RIGHT CORONARY ARTERY FOR A SIGNIFICANT ULCERATED STENOSIS; PROCEDURE WAS UNEVENTFUL (FU1). ON (B)(6) 2025, THE PATIENT WAS DISCHARGED HOME (FU1). ON (B)(6) 2025, THE PATIENT WAS REASSESSED BY THE PRINCIPAL INVESTIGATOR. CLINICAL STATUS REMAINED UNCHANGED SINCE DISCHARGE ON (B)(6) 2025 (FU2). ON (B)(6) 2025, CLINICAL STATUS REMAINED UNCHANGED. PROGRESSIVE RESUMPTION OF PREVIOUS ACTIVITIES WAS CONSIDERED POSSIBLE. A REHABILITATION AND EXERCISE RECONDITIONING PROGRAM WAS PLANNED FOR LATE (B)(6) 2025 (FU3). THE PATIENT UNDERWENT AN INPATIENT REHABILITATION AND EXERCISE RECONDITIONING PROGRAM FROM (B)(6) 2025 TO (B)(6) 2025, INCLUDING GAIT RETRAINING. WALKING TESTS WERE PERFORMED ON (B)(6) 2026 (FU4). THE KEEOGO DEVICE WAS INSPECTED BY THE STUDY TEAM AND CONFIRMED TO BE FUNCTIONING PROPERLY BEFORE, DURING, AND AFTER THE INCIDENT, WITH NO DEFECT OR MALFUNCTION IDENTIFIED. THE INVESTIGATOR NOTED THE POSSIBILITY THAT THE PHYSICAL EFFORT REQUIRED WHILE USING THE DEVICE DURING EXERCISE MAY HAVE CONTRIBUTED TO THE EVENT. THE SUBJECT WAS WITHDRAWN FROM THE STUDY FOLLOWING THIS EVENT. THE RESEARCH PROCEDURE WAS DEFINITIVELY DISCONTINUED AS OF (B)(6) 2025 (FU1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507464 KEEOGO - CLINICIAN KIT KEEOGO - CLINICIAN KIT PHL B-TEMIA INC 5062601 N/A 07540162060007

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Hospitalization| O| L| R NO CONCOMITANT MEDICATIONS REPORTED BY SITE.| PHYSICAL REHAB THERAPY (SUPERVISED SESSION).