MAUDE Adverse Event Report: CYMEDICA ORTHOPEDICS, INC. CYMEDICA ORTHOPEDICS E-VIVE; CYMEDICA ORTHOPEDICS® E-VIVE¿

Model Number	CY-1000-310
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	10/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The observed trauma is indicative of an acute localized increase in current density as a result of loss of pad conductivity across its surface area.Many potential sources exist of accidental high current densities.Wrinkles or breaks in electrode conductors, non-uniform gel layer or damage, drying out, electrodes partially peeling off the skin (loss of adhesion), incorrect electrode placement and electrode design can create preferential current through a reduced surface area into the patient resulting unsafe current densities and subsequent tissue damage.This can occur even at safe therapeutic impulses due to the reduction of the conductive surface area resulting in unsafe current densities.In the absence of the physical complaint device to investigate, photo and testimony evidence was investigated as follows: the complaint device electrode photos were examined as follows: wrinkles: no sign of damage.Breaks: no sign of damage.Gel: substantial perimeter damage indicative of excessive use and poor maintenance dryness: photos are commensurate with dry electrodes.Adhesion: photos are commensurate with compromised adhesion due to dryness.Incorrect electrode placement: unknown, photos of injuries suggest correct placement on leg.The complaint device was examined for: garment inspected, no abnormalities.Fault conditions, no overvoltage faults reported.Root causes: patient negligence of replacing dry electrodes.As the electrodes are used, moisture is lost due to thermal heating.Consequently, increasing resistance, which then requires elevated intensity levels to achieve strong contractions.This leads to a greater electrical potential and thus a propensity of higher current densities.Patient negligence of using electrode gel to facilitate current density distribution at higher therapy levels.
Event or Problem Description
On (b)(6) 2020 patient contacted cymedica customer service regarding burns he received from the electrodes.The "burn" marks are healed now; please take note that he used the same set of pads since late august.The patient did not use gel.Customer service shipped him new electrodes and re-educated him on use/care etc.

• Brand Name: CYMEDICA ORTHOPEDICS E-VIVE
• Common Device Name: CYMEDICA ORTHOPEDICS® E-VIVE¿
• Manufacturer (Section D): CYMEDICA ORTHOPEDICS, INC.; 19120 n. pima road; suite 135; scottsdale AZ 85255
• MDR Report Key: 10920525
• Report Number: 3011466827-2020-00004
• Device Sequence Number: 16805489
• Product Code: IPF
• UDI-Device Identifier: 00854691008834
• UDI-Public: 00854691008834
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K163067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 11/05/2020

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: 07/21/2022
• Device Model Number: CY-1000-310
• Device Catalogue Number: CY-1000-310
• Device Lot Number: 0214885-0147
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/30/2020
• 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: 55 YR
• Patient Weight: 73