MAUDE Adverse Event Report: CYMEDICA ORTHOPEDICS, INC. CYMEDICA ORTHOPEDICS QB1 NEUROMUSCULAR ELECTRICAL STIMULATION (NMES) SYSTEM; CYMEDICA ORTHOPEDICS® QB1 NEUROMUSCULAR ELECTRICAL STIMULATION (NMES) SYSTEM

Model Number QB-1000-216

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Burning Sensation (2146); Superficial (First Degree) Burn (2685)

Event Date 10/06/2020

Event Type  Injury  

Manufacturer Narrative

On october 7, 2020, (b)(6), contacted cymedica orthopedics stating the following: "we had to cancel a patient's surgery today due to wounds on his upper leg which he believes were from the e-vive machine.Pictures of the wounds are attached.He began using the machine 2 weeks ago and had been using it every day, twice per day for 20 minutes at a time.He developed the wounds 3 days ago but couldn't recall if it was from the strap or a possible burn?" the above statement from the pa mentions an e-vive machine; however, this device was a qb1 system and not an e-vive system.Event timeline: fitting date: (b)(6) 2020 injury notification date: 10/6/20 ((b)(6) 2020 last treatment) ~13 days treatment time: 8hrs 49min treatments completed: 26.45 treatment level: initially levels at 50-60, sustained levels at 100 avg daily treatments: 2 per day no gel usage original electrodes cymedica customer service contacted the patient on 07-oct-2020 and obtained additional details related to this event.Patient stated that he had been using the same original set of electrodes since (b)(6) 2020, approximate treatment sessions of 23 times.Patient stated he had applied the treatment intensities at maximum intensity levels of 100 for both knee and thigh areas.A review of device history record (dhr) showed this device including the stim generator, garment, and electrodes had met all the applicable manufacturing specifications.Additional investigation and bench testing of the returned device was performed to assure the device had not been damaged when in use.Device info: shipped out 8/23/20, returned 10/13/20; stim generator or user interface (ui) shows 8 hours 49 minutes runtime upon receipt.On october 15, 2020, during the returned device investigation, it was found that the complaint could not be re-created.Initial impressions: electrodes appeared a bit dry; ui functioned normally and recognized garment nmes board; electrode lead wires are continuous; ui was able to perform 2 full 20 minute stimulation cycles nmes board resistance measurements (rf: 1.603kohm, vmo: 1.601kohm) within acceptable range (1575-1625ohm).The test equipment included asset 078; due 10/20/20, asset 015; due 2/11/21).User interface measurements found to be within manufacturing specifications for 500 ohm, 2k ohm, and 10k ohm to data from qb-0035-048.The test equipment included asset 015; due 2/11/21.Waveform captures at intensity levels 1, 50, and 100 found to have a correct and expected waveform shape.Using the same returned device, a stimulation session exercised on tester with new electrodes and found to be comfortable with as-expected experience.No skin burns or damage was observed under the electrodes.The complaint device electrodes were examined for wrinkles, breaks, gel damage, dryness, adhesion, incorrect electrode placement and electrode design.·wrinkles: no sign of damage ·breaks: no sign of damage ·dryness: the electrodes appeared dry.·adhesion: compromised, indicative of repeated application and removal of electrodes when compared to fresh electrodes.·incorrect electrode placement: unknown, photos of injuries suggest correct placement on leg.The complaint device was examined for: ·abnormal energy output intensities and waveform shape are within tolerance.·fault conditions, none reported.·user interface measurements are within tolerance.- nmes pcba is within tolerance.·wire continuity pass inspection.·board resistance and user interface measurements are within tolerance.·garment inspected, no abnormalities ·therapy applied (new electrodes) by investigator, no abnormalities.Root causes: we believe use of the device at maximum intensities of 100 and not changing the electrodes for a long period of time since their initial use by the patient caused the ultimate skin damage.The electrodes provided with the qb1 system are hydrogel based electrodes.They water content in the hydrogel can dry up with time especially when exposed in the air.This process accelerates when the electrodes are in use and specially when high levels of treatment intensities are applied.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.Qb1 system instructions for use (ifu or user guide) provides information about the electrodes and frequency needed to change the electrodes.In addition, the patients are trained about electrodes change during the device dispensing process.Mitigation strategies: 1)update ifu and supporting literature to reinforce the requirements for hydrogel usage and frequent electrode replacement.

Event Description

On (b)(6) 2020, (b)(6) contacted cymedica orthopedics and reported the following."we had to cancel a patient's surgery today due to wounds on his upper leg which he believes were from the e-vive machine.He began using the machine 2 weeks ago and had been using it everyday, twice per day for 20 minutes at a time.He developed the wounds 3 days ago but couldn't recall if it was from the strap or a possible burn?".

• Brand Name: CYMEDICA ORTHOPEDICS QB1 NEUROMUSCULAR ELECTRICAL STIMULATION (NMES) SYSTEM
• Type of Device: CYMEDICA ORTHOPEDICS® QB1 NEUROMUSCULAR ELECTRICAL STIMULATION (NMES) SYSTEM
• Manufacturer (Section D): CYMEDICA ORTHOPEDICS, INC.; 19120 n. pima ave.; suite 135; scottsdale AZ 85255
• Manufacturer (Section G): CYMEDICA ORTHOPEDICS, INC.; 19120 n. pima road; suite 135; scottsdale AZ 85255
• Manufacturer Contact: jackie clemons ; 19120 n. pima road; suite 135; scottsdale, AZ 85255 ; 4806642547
• MDR Report Key: 10713187
• MDR Text Key: 212348527
• Report Number: 3011466827-2020-00002
• Device Sequence Number: 1
• Product Code: IPF
• UDI-Device Identifier: 00854691008254
• UDI-Public: 00854691008254
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/30/2022
• Device Model Number: QB-1000-216
• Device Catalogue Number: QB-1000-216
• Device Lot Number: 17002573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 85 YR
• Patient Weight: 88