MAUDE Adverse Event Report: ACTEGY LTD REVITIVE MEDIC 2469MD; CIRCULATION BOOSTER

Model Number REVITIVE MEDIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

Investigative actions and timeline: patient's daughter has reported that the patient has a medical history of good health with no reported co-morbidities, previous annual check up revealed no issues and reported excellent health taking age into consideration.Device has been requested for return to the manufacturer to enable further investigation.Device received and tested 24 oct 2016 - no faults found, device is working within specification.A medical opinion has been requested.Update: medical opinion has been received from professor (b)(6), professor of physiotherapy."given the nature of the applied stimulation with the revitive family of devices, it is very difficult to identify a mechanism through which the stimulation could have directly caused the reported pulmonary emboli.The device appears to have been employed using the foot pads only and at an intensity sufficient to bring about muscle contraction(s) in the calf.The operating circumstances (treatment time, treatment frequency, treatment intensity) appear to be entirely consistent with the recommendations in the device supporting literature.The only link i can propose (but which can not be established from the available documentation) is that if the patient had an undiagnosed dvt in the calf and vigorous nmes type stimulation was applied, it is a possibility that the clot or a part thereof, could have become dislodged and given rise of the reported emboli.The documentation which accompanies the device clearly states that it should not be employed if the user has a dvt, and furthermore, describes, in lay terms, the key features of a dvt.This guidance is consistent with the documentation that is provided with all similar machines (for both professional and otc use).The professional (therapist) guidelines available, including those specific to physiotherapists in (b)(6) (electrophysical agents: contraindications and precautions: an evidence-based approach to clinical decision making in physical therapy, physiotherapy (b)(6) 62(5) special issue: 2010, issn-0300-0508, e-issn-1708-8313) states that nmes should not be applied to persons with active deep vein thrombosis or thrombophlebitis.The rationale (cited from the (b)(6) (2010) document, p30) states: "muscle contraction induced by nmes applied near a dvt could dislodge a thrombus that could then embolize a vital organ, causing infarction, shortness of breath, stroke, or major organ failure.Reflex vasodilatation and increased blood flow to contralateral limbs and/or peripheral sites induced by e-stim could also embolize a blood clot.The csp guidelines and many of the resources suggest that e-stim is safe provided that treatment of the dvt affected limb is avoided (c-local).Although the risk of e-stim's dislodging a thrombus is low, the consequences of a thrombus's travelling to a vital organ could be catastrophic." it is important to emphasise the risk of nmes stimulation over an area where a dvt is present giving rise to emboli is identified as being low.The only way in which i can envisage further clarification is if it can be identified from the patient medical records that a dvt was present (it would be normal for the medic responsible to investigate this specific issue).Although this may appear to constitute a direct cause-effect potential, the magnitude of the muscle contractions in the calf brought about by the revitive stimulation is not a contraction level over and above that which is achieved in normal everyday functional activity (e.G.Walking, stair climbing), and therefore, if the dvt clot was 'unstable', it is entirely possible that some other activity, not the revitive stimulation, may have been responsible for the clot displacement.I do not believe there is any evidence that electrical stimulation in the calf can cause a dvt or enhance its onset.There is published research evidence which indicates that electrical stimulation to the muscle(s) in the calf can in fact significantly reduce the risk of dvt.Without further evidence from the medical record(s), it is not possible to step beyond this speculative position.Even if there was evidence of a dvt in one or other calf in this patient, it would not be possible, in my opinion, to state categorically, that the application of the revitive stimulation was responsible for clot displacement.I believe that the information in the information for users provided with the device does identify that revitive should not be employed where a dvt is present or is suspected, and describes the signs and symptoms of a dvt in lay terms.Permission for medical advisor to obtain further information from treating physician has also been requested from patient's daughter.Patient has requested to withhold medical records until results from specialist have been received.Final update: further requests have been made both in writing (recorded post), phone and email.Further investigation is not possible as permission to access medical records is currently denied.If access to medical records is granted, actegy will re-open the case to enable further investigation.

Event Description

Please note: following an fda inspection at actegy ltd between march 5-8, 2018 by mr.(b)(4) it was identified this incident should have been reported to fda.Therefore, the following incident is being reported retrospectively: (b)(6) female purchased a revitive device (model unknown) to improve circulation in her legs.Used the device once a day for a period of 20-30 minutes for 6 days ((b)(6) 2016 inclusive).Following use of the device on the 6th day ((b)(6) 2016) the user experienced pain in her legs.During the night of (b)(6) the patient awoke with pain under her right rib and could not breathe deeply.The following day ((b)(6)), the patient did not use the revitive device, but awoke during the night with the same problem of pain under right rib.The patient is no longer experiencing pain and is able to breathe normally.The patient has discontinued use of the revitive device.

• Brand Name: REVITIVE MEDIC 2469MD
• Type of Device: CIRCULATION BOOSTER
• Manufacturer (Section D): ACTEGY LTD; reflex; cain road; bracknell, berkshire RG12 1HL; UK RG12 1HL
• Manufacturer (Section G): MIRA MEDI & TECH CO., LTD; 22 baeksuk-dong 5-gil; seobuk-gu; cheonan city, ; KS
• Manufacturer Contact: lawrence brookfield ; reflex; cain road; bracknell, berkshire RG12 -1HL ; UK RG12 1HL
• MDR Report Key: 7553039
• MDR Text Key: 109577945
• Report Number: 3010078417-2018-00004
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K152480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: REVITIVE MEDIC
• Device Catalogue Number: 2469MD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2016
• Was the Report Sent to FDA?: No
• Device Age: 2 YR
• Event Location: Home
• Date Manufacturer Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 87 YR