MAUDE Adverse Event Report: CYMEDICA ORTHOPEDICS, INC. CYMEDICA ORTHOPEDICS E-VIVE; E-VIVE¿ NEUROMUSCULAR ELECTRICAL STIMULATION (NMES) SYSTEM

Model Number	CY-1000-216
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Muscle Stimulation (1412); Tissue Damage (2104); Burning Sensation (2146)
Date of Event	02/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2020, a clinical subject reported an electrode burn to the site which was documented as an adverse event.Upon further discussions with the crc on (b)(6) 2020, it was discovered the subject was applying an excessive amount of electrode gel which would cause electrode damage.The crc potentially had instructed the subject to apply skin lotion since she has instructed other subjects to do the same.The sponsor discussed with the crc that applying lotion before a treatment could generate additional heat and cause skin irritation and/or burn.The crc was asked to contact the subject and have her stop applying skin lotion and an excessive amount of electrode gel.The sponsor also instructed the crc to communicate to the subject, at any sign of electrode damage the electrodes must be replaced.The subject is currently enrolled in the clinical trial and was instructed by the principal investigator to stop using the device for two days.At the conclusion of the two days, the subject can resume using the device and remain in the study.
Event or Problem Description
The patient/subject is currently enrolled in (b)(6) clinical study ((b)(6)).On (b)(6) 2020, the subject notified the site that she had marks consistent with a burn in the location of the device electrodes.Treatment was temporarily stopped for 2 days then resumed on (b)(6) 2020 under the care of the principal investigator.

• Brand Name: CYMEDICA ORTHOPEDICS E-VIVE
• Common Device Name: E-VIVE¿ NEUROMUSCULAR ELECTRICAL STIMULATION (NMES) SYSTEM
• Manufacturer (Section D): CYMEDICA ORTHOPEDICS, INC.; 19120 n. pima road; suite 135; scottsdale, az
• MDR Report Key: 9835882
• Report Number: 3011466827-2020-00001
• Device Sequence Number: 14058790
• Product Code: GZJ
• UDI-Device Identifier: 00854691008414
• UDI-Public: 00854691008414
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2020
• Report Date (Section F): 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/03/2021
• Device Model Number: CY-1000-216
• Device Catalogue Number: CY-1000-216
• Device Lot Number: 1939-007205
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/25/2020
• Device Age: 2 MO
• Event Location: Home
• Date Report to Manufacturer: 02/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Weight: 77