MAUDE Adverse Event Report: NATUS MANUFACTURING LIMITED CLAVIS EMG/STIM DEVICE

Model Number 9015A0012

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Muscle Weakness (1967)

Event Date 05/25/2023

Event Type  malfunction  

Event Description

Part 9015a0012 - clavis emg/stim device.During a review of a literature report (j rehabil med 2023; 55: jrm11963 results page 4).With reference to effectiveness of ultrasound-guided vs electrical-stimulationguided botulinum toxin injections in triceps surae spasticity afterstroke: a randomized controlled study, the following information was documented: wound on the outside of the ankle - linked to a conflict with a splint, is more related to the recurrence of spasticity.

Manufacturer Narrative

Initial report (ref natus complaint #(b)(4)).Natus to reach out for further information to ensure all related details are received and document.Lot / serial number to be confirmed.The report was written by: isabelle hauret, md, msc1, lech dobija, pt, msc1, pascale givron, md1, anna goldstein, md, msc1, bruno pereira, phd2 and emmanuel coudeyre, md, phd1.From the 1departement of physical and rehabilitation medicine, clermont-ferrand university hospital, clermont auvergne university, institut national de recherche agrononomique et environnement, france and 2innovation and clinical research, clermont-ferrand university hospital, clermont-ferrand, france.

Event Description

Part 9015a0012 - clavis emg/stim device.During a review of a literature report (j rehabil med 2023; 55: jrm11963 results page 4).With reference to effectiveness of ultrasound-guided vs electrical-stimulationguided botulinum toxin injections in triceps surae spasticity afterstroke: a randomized controlled study, the following information was documented: wound on the outside of the ankle - linked to a conflict with a splint, is more related to the recurrence of spasticity.

Manufacturer Narrative

Follow up 001 ref natus complaint# (b)(4).It was confirmed that this event was not related to the dantec clavis device.The device was not returned for investigation as the study author confirmed that the adverse effects noted were not due to the dantec clavis device.A device history record review is not applicable as the author of the study confirmed that the dantec clavis device did not malfunction or cause the adverse event.No serial number was provided by the study author as they confirmed the adverse effects noted were not due to a malfunction of the dantec clavis device.Complaints are reviewed routinely per quality system requirements (qms-004442 corporate trending and analysis procedure) complaint trends are assessed as part of these reviews.A review of complaint trending is completed quarterly.Last review doc-(b)(4).Faillure confirmed: no ,= investigation result code: neuro sbu|no issues noted.Closure rationale: complaint could not be verified, monitor for future occurrence.

• Brand Name: CLAVIS EMG/STIM DEVICE
• Type of Device: CLAVIS EMG/STIM DEVICE
• Manufacturer (Section D): NATUS MANUFACTURING LIMITED; ida business park; gort; galway, h91pd92, ; EI
• Manufacturer (Section G): NATUS MEDICAL INCORPORATED; dba excel-tech ltd.; 2568 bristol circle; oakville, ontarios, l6h 5s1, ; CA
• Manufacturer Contact: gráinne walsh ; ida business park; gort; galway, h91 pd92, ; EI
• MDR Report Key: 17964121
• MDR Text Key: 326015995
• Report Number: 3005581270-2023-00005
• Device Sequence Number: 1
• Product Code: BXN
• UDI-Device Identifier: 00382830049702
• UDI-Public: 00382830049702
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K062478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9015A0012
• Device Catalogue Number: 9015A0012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1