MAGNETOLITH

Description of Event or Problem

AS PER MANUFACTURER INCIDENT REPORT RECEIVED FROM THE MANUFACTURER IN SWITZERLAND. A 38 YEAR OLD MALE WITHOUT ANY KNOWN PRE-EXISTING MEDICAL CONDITIONS WAS TREATED FOR SHOULDER PROBLEMS (RIGHT SIDE) AT A PHYSIOTHERAPY CLINIC IN (B)(6) FRANCE. THE TREATING PHYSIOTHERAPIST REPORTED THAT THE PATIENT FELT UNWELL AND PASSED OUT DURING TREATMENT; WHAT HE (THE PHYSIOTHERAPIST) JUDGED TO BE A CARDIAC ARREST. THE PATIENT WAS SUCCESSFULLY RESUSCITATED (CHEST COMPRESSION) BY THE PHYSIOTHERAPIST. A MEDICAL DOCTOR WHO WAS ON SITE WHEN THE INCIDENT HAPPENED NOTICED A LOSS OF PULSE. THE PATIENT REGAINED CONSCIOUSNESS AFTER 1 OR 2 MINUTES. WHEN THE PARAMEDICS ARRIVED, THEY DID NOT USE THE DEFIBRILLATOR AND THE ECG DID NOT REVEAL ANY ABNORMALITIES. THE PATIENT WAS THEN TAKEN TO THE EMERGENCY DEPARTMENT BY THE PARAMEDICS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY ((B)(6) 2021) WITH THE DISCHARGE DIAGNOSIS OF CARDIAC ARREST. THE CAUSE OF THE CARDIAC ARREST COULD NOT BE DETERMINED BY THE HOSPITAL MEDICAL STAFF. MRI OF THE PATIENT'S CHEST (LUNGS) DID SHOW SIGNS OF A PREVIOUS COVID-19 INFECTION (ASYMPTOMATIC AS THE PATIENT WAS NOT AWARE OF AN INFECTION). THE PATIENT HAS NOT BEEN REFERRED TO A CARDIOLOGIST FOR FURTHER EXAMINATION AND NO DRUG TREATMENT HAS BEEN PRESCRIBED. ON (B)(6) 2021, THE PATIENT REPORTED FEELING GOOD AND RECOVERED, AND HAS RETURNED TO WORK.

Additional Manufacturer Narrative

THE USER DID NOT REPORT A DEVICE PROBLEM OR MALFUNCTION. WE RETRIEVED THE DEVICE FROM THE USER ON (B)(6) 2021. ON (B)(6) 2021, WE EMPLOYED RELEVANT EMPIRICAL TESTING (EG, BASIC SAFETY, ELECTROMAGNETIC FIELD STRENGTH AND INSULATION TEST) OF THE ACTUAL DEVICE SUSPECTED IN THE REPORTED ADVERSE EVENT IN ORDER TO ESTABLISH ITS FUNCTIONAL AND OTHER PROPERTIES AND TO IDENTIFY POSSIBLE CAUSES FOR THE ADVERSE EVENT. NO DEVICE PROBLEM HAS BEEN DETECTED. THE INVESTIGATION ALSO INVOLVED FURTHER TYPES OF INVESTIGATIONS TO DETERMINE IF A CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND INCIDENT IS PLAUSIBLE. FOR THIS, WE DID EMPLOY FURTHER COMMUNICATION/INTERVIEWS (THROUGH TECHNICAL MEANS, E.G. PHONE, E-MAIL) WITH THE HEALTHCARE PROFESSIONAL (PHYSIOTHERAPIST) AND THE AFFECTED PATIENT. WE ALSO RETRIEVED HISTORICAL ADVERSE EVENT DATA (FROM INTERNAL COMPLAINT DATABASE, SCIENTIFIC LITERATURE, PUBLICLY ACCESSIBLE DATABASES OF ADVERSE EVENTS) OF THE SAME AND SIMILAR DEVICES (PULSED ELECTROMAGNETIC FIELD THERAPY; PEMF). A PRELIMINARY ANALYSIS OF THESE DATA, HOWEVER, DID NOT REVEAL EVIDENCE OF A RELATIONSHIP BETWEEN ELECTROMAGNETIC FIELD THERAPY AND CARDIAC ARREST EITHER. AT THE MOMENT, WE CANNOT EXCLUDE THE POSSIBILITY THAT THIS PARTICULAR ADVERSE EVENT OCCURRED DUE TO COINCIDENCE. THE INCIDENCE OF SUDDEN CARDIAC DEATH IN THE GENERAL POPULATION HAS BEEN ESTIMATED AS 1 PER 1,000 PERSON-YEARS. THIS RISK MIGHT EVEN BE INCREASED BY COVID-19 INFECTION. MRI OF THE PATIENT'S CHEST (LUNG) DID SHOW SIGNS OF A PREVIOUS COVID-19 INFECTION (ASYMPTOMATIC AS THE PATIENT WAS NOT AWARE OF AN INFECTION). RECENT EVIDENCE SUGGESTS THAT EVEN IN PEOPLE WITH NO OR MILD / MODERATE COVID-19 SYMPTOMS, THERE IS THE POSSIBILITY THAT THE VIRUS MAY CAUSE HEART DAMAGE THAT CAN LEAD TO COMPLICATIONS INCLUDING HEART ARRHYTHMIAS, HEART FAILURE AND SUDDEN CARDIAC DEATH (ABDELRADI A, YEKTA A. CUREUS. 2021 JUN 27;13(6):E15952; PUNTMANN ET AL. JAMA CARDIOL. 2020 NOV 1;5(11):1265-1273). WE WILL THOROUGHLY ANALYSE THE INFORMATION PROVIDED BY THE HEALTHCARE PROFESSIONAL / PATIENT. WE WILL ALSO REVIEW HISTORICAL ADVERSE EVENT DATA / CLINICAL DATA FROM THE LITERATURE AND CONSULT WITH OUR CLINICAL EXPERT (CARDIOLOGIST). FINALLY, WE WILL REVIEW OUR RISK ASSESSMENT.

Additional Manufacturer Narrative

THE USER DID NOT REPORT A DEVICE PROBLEM OR MALFUNCTION. WE RETRIEVED THE DEVICE FROM THE USER ON (B)(6) 2021. ON (B)(6) 2021, WE EMPLOYED RELEVANT EMPIRICAL TESTING (EG, BASIC SAFETY, ELECTROMAGNETIC FIELD STRENGTH AND INSULATION TEST) OF THE ACTUAL DEVICE SUSPECTED IN THE REPORTED ADVERSE EVENT IN ORDER TO ESTABLISH ITS FUNCTIONAL AND OTHER PROPERTIES AND TO IDENTIFY POSSIBLE CAUSES FOR THE ADVERSE EVENT. NO DEVICE PROBLEM HAS BEEN DETECTED. THE INVESTIGATION ALSO INVOLVED FURTHER TYPES OF INVESTIGATIONS TO DETERMINE IF A CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND INCIDENT IS PLAUSIBLE. FOR THIS, WE DID EMPLOY FURTHER COMMUNICATION/INTERVIEWS (THROUGH TECHNICAL MEANS, E.G. PHONE, E-MAIL) WITH THE HEALTHCARE PROFESSIONAL (PHYSIOTHERAPIST) AND THE AFFECTED PATIENT. WE ALSO RETRIEVED HISTORICAL ADVERSE EVENT DATA (FROM INTERNAL COMPLAINT DATABASE, SCIENTIFIC LITERATURE, PUBLICLY ACCESSIBLE DATABASES OF ADVERSE EVENTS) OF THE SAME AND SIMILAR DEVICES (PULSED ELECTROMAGNETIC FIELD THERAPY; PEMF). A PRELIMINARY ANALYSIS OF THESE DATA, HOWEVER, DID NOT REVEAL EVIDENCE OF A RELATIONSHIP BETWEEN ELECTROMAGNETIC FIELD THERAPY AND CARDIAC ARREST EITHER. AT THE MOMENT, WE CANNOT EXCLUDE THE POSSIBILITY THAT THIS PARTICULAR ADVERSE EVENT OCCURRED DUE TO COINCIDENCE. THE INCIDENCE OF SUDDEN CARDIAC DEATH IN THE GENERAL POPULATION HAS BEEN ESTIMATED AS 1 PER 1,000 PERSON-YEARS. THIS RISK MIGHT EVEN BE INCREASED BY COVID-19 INFECTION. MRI OF THE PATIENT'S CHEST (LUNG) DID SHOW SIGNS OF A PREVIOUS COVID-19 INFECTION (ASYMPTOMATIC AS THE PATIENT WAS NOT AWARE OF AN INFECTION). RECENT EVIDENCE SUGGESTS THAT EVEN IN PEOPLE WITH NO OR MILD / MODERATE COVID-19 SYMPTOMS, THERE IS THE POSSIBILITY THAT THE VIRUS MAY CAUSE HEART DAMAGE THAT CAN LEAD TO COMPLICATIONS INCLUDING HEART ARRHYTHMIAS, HEART FAILURE AND SUDDEN CARDIAC DEATH (ABDELRADI A, YEKTA A. CUREUS. 2021 JUN 27;13(6):E15952; PUNTMANN ET AL. JAMA CARDIOL. 2020 NOV 1;5(11):1265-1273). WE WILL THOROUGHLY ANALYSE THE INFORMATION PROVIDED BY THE HEALTHCARE PROFESSIONAL / PATIENT. WE WILL ALSO REVIEW HISTORICAL ADVERSE EVENT DATA / CLINICAL DATA FROM THE LITERATURE AND CONSULT WITH OUR CLINICAL EXPERT (CARDIOLOGIST). FINALLY, WE WILL REVIEW OUR RISK ASSESSMENT. FINAL REPORT: THE INVESTIGATION ALSO INVOLVED FURTHER TYPES OF INVESTIGATIONS TO DETERMINE IF A CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND INCIDENT IS PLAUSIBLE. WE RETRIEVED HISTORICAL ADVERSE EVENT DATA OF THE SAME (MAGNETOLITH) AND SIMILAR PEMF DEVICES FROM: 1. OUR INTERNAL COMPLAINT / VIGILANCE DATABASES; 2. SCIENTIFIC LITERATURE (PUBMED); 3. PUBLICLY ACCESSIBLE DATABASES OF ADVERSE EVENTS. FINDINGS. 1. INTERNAL COMPLAINT /VIGILANCE DATABASES: THERE ARE NO OTHER REPORTS OF ARRHYTHMIAS OR CARDIAC ARREST IN OUR COMPLAINT / VIGILANCE DATABASES. 2. SCIENTIFIC LITERATURE: WE DID NOT FIND ANY REPORT OF CARDIAC ARRHYTHMIAS OR CARDIAC ARREST IN HUMANS. IN VIVO ANIMAL STUDIES AND HUMAN EXPOSURE STUDIES DID NOT REVEAL ANY CLINICALLY RELEVANT CARDIOVASCULAR CHANGES. IN VIVO ANIMAL DATA ALSO SUGGEST THAT THE THRESHOLD FOR CARDIAC STIMULATION IS ALMOST 3 ORDER OF MAGNITUDE HIGHER THAN THE MAGNETIC FIELD STRENGTH OF THE MAGNETOLITH DEVICE (12 KJ VS. 19 J). WHILE MOST STUDIES DID USE LOWER PULSE FREQUENCIES THAN THE MAGNETOLITH DEVICE, EVIDENCE SUGGESTS THAT THE PROBABILITY OF NEURONAL ACTIVATION IS EVEN LOWER WITH HIGHER FREQUENCIES. CONCLUSION. SINCE 2019, (B)(4) MAGNETOLITH DEVICES HAVE BEEN PLACED ON THE MARKET AND PUT INTO SERVICE WORLDWIDE. ASSUMING 5 TO 10 TREATMENTS PER DEVICE PER DAY (ESTIMATE BASED ON RESULTS FROM USER SURVEY), 250 DAYS A YEAR, WE ESTIMATE THAT APPROX. 0.6 TO 1.2 MILLION TREATMENTS IN TOTAL HAVE BEEN PERFORMED SO FAR. COMPARED WITH THIS, OUR PMS ACTIVITIES AND LITERATURE SEARCH DID NOT RETRIEVE ANY RELEVANT ADVERSE EVENT REPORTS. AT THE CENTRE POINT OF THE HANDPIECE (COIL) OF THE MAGNETOLITH DEVICE, A MAGNETIC FIELD WITH A FIELD STRENGTH OF AROUND 80 MT IS GENERATED. HOWEVER, SINCE THE PATIENT WAS TREATED AT THE RIGHT SHOULDER, THE CENTRE POINT OF THE COIL WAS APPROX. 20 TO 25 CM AWAY FROM THE HEART. BASED ON THIS ASSUMPTION, THE ESTIMATED FIELD STRENGTH ABOVE THE HEART IS REDUCED TO APPROX. 2-4 MT. IN A RANDOMISED TRIAL OF THE MAGNETOLITH DEVICE IN 86 PATIENTS WITH ROTATOR CUFF TENDINOPATHY, THE TREATMENT WAS APPLIED TO THE LEFT SHOULDER IN 41 OF THE PARTICIPANTS. NO ADVERSE EVENTS WERE REPORTED, SUPPORTING THE SAFE USE OF THE DEVICE EVEN IN CLOSER VICINITY TO THE HEART (APPROX. 10 CM FROM CENTRE POINT OF THE COIL) AND THUS MUCH HIGHER FIELD STRENGTH (APPROX. 19 MT) THAN ESTIMATED FOR THE INCIDENT. IN CONCLUSION, WE COULD NOT IDENTIFY EVIDENCE INDICATING THAT THE MAGNETOLITH DEVICE COULD INDUCE CLINICALLY RELEVANT CHANGES IN CARDIAC ACTIVITY THAT IN TURN COULD LEAD TO CARDIAC ARREST. WE DID NOT IDENTIFY NEW RISKS THAT MUST BE ADRESSED IN THE RISK ASSESSMENT. WE ALSO CONSULTED WITH OUR CLINICAL EXPERT (CARDIOLOGIST), WHO CONCLUDED FROM THE EVENT DESCRIPTION THAT A PAIN-INDUCED VAGAL SYNCOPE WAS MORE LIKELY THAN CARDIAC ARREST. WE THUS CONCLUDE THAT THIS PARTICULAR ADVERSE EVENT OCCURRED DUE TO COINCIDENCE.

Description of Event or Problem

AS PER MANUFACTURER INCIDENT REPORT RECEIVED FROM THE MANUFACTURER IN SWITZERLAND. A 38 YEARS OLD MALE WITHOUT ANY KNOWN PRE-EXISTING MEDICAL CONDITIONS WAS TREATED FOR SHOULDER PROBLEMS (RIGHT SIDE) AT A PHYSIOTHERAPY CLINIC IN (B)(6), FRANCE. THE TREATING PHYSIOTHERAPIST REPORTED THAT THE PATIENT FELT UNWELL AND PASSED OUT DURING TREATMENT; WHAT HE (THE PHYSIOTHERAPIST) JUDGED TO BE A CARDIAC ARREST. THE PATIENT WAS SUCCESSFULLY RESUSCITATED (CHEST COMPRESSION) BY THE PHYSIOTHERAPIST. A MEDICAL DOCTOR WHO WAS ON SITE WHEN THE INCIDENT HAPPENED NOTICED A LOSS OF PULSE. THE PATIENT REGAINED CONSCIOUSNESS AFTER 1 OR 2 MINUTES. WHEN THE PARAMEDICS ARRIVED, THEY DID NOT USE THE DEFIBRILLATOR AND THE ECG DID NOT REVEAL ANY ABNORMALITIES. THE PATIENT WAS THEN TAKEN TO THE EMERGENCY DEPARTMENT BY THE PARAMEDICS. THE PATIENT WAS DISCHARGED FROM HOSPITAL THE NEXT DAY ((B)(6) 2021) WITH THE DISCHARGE DIAGNOSIS OF CARDIAC ARREST. THE CAUSE OF THE CARDIAC ARREST COULD NOT BE DETERMINED BY THE HOSPITAL MEDICAL STAFF. MRI OF THE PATIENT'S CHEST (LUNGS) DID SHOW SIGNS OF A PREVIOUS COVID-19 INFECTION (ASYMPTOMATIC AS THE PATIENT WAS NOT AWARE OF AN INFECTION). THE PATIENT HAS NOT BEEN REFERRED TO A CARDIOLOGIST FOR FURTHER EXAMINATION AND NO DRUG TREATMENT HAS BEEN PRESCRIBED. ON (B)(6), THE PATIENT REPORTED FEELING GOOD AND RECOVERED, AND HAS RETURNED TO WORK.