MAUDE Adverse Event Report: EBI, LLC. SOFT-TOUCH ELECTRODES, 72R; STIMULATOR, SPINAL PAK, NON-INVASIVE (72R ELECTRODES)

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rash (2033); Burning Sensation (2146); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

It was reported that the patient started using the 72r electrodes for one hour the first day and felt some itching about 3 hours after removing them but couldn't decided if it was dry skin or not.The patient waited until the entire area had cleared up.Yesterday, the patient stated they put the electrodes on for 2 hours.About 2 hours later the area around the where the electrodes were was red and the whole area burned like sunburn and itched like fire.The patient put steroid cream on the rash and it did not help.The patient stated they "took (b)(6) and all it did was put me to sleep".The area still burns and itches though, not as bad as last night.The area where the electrodes were is faint red, the patient not sure what to do.He is very concerned about fusion now that he is not using the bone growth stimulator.The patient used cortizone.The patient does not have sensitive skin.It was later reported that the physician advised the patient to discontinue using the device.No additional patient consequences have been reported.

Manufacturer Narrative

Zimmer biomet complaint# (b)(4).Date of event: the event occurred sometime in january 2022.Medical product: unknown.Therapy date: unknown.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient started using the 72r electrodes for one hour the first day and felt some itching about 3 hours after removing them but couldn't decided if it was dry skin or not.The patient waited until the entire area had cleared up.Yesterday, the patient stated they put the electrodes on for 2 hours.About 2 hours later the area around the where the electrodes were was red and the whole area burned like sunburn and itched like fire.The patient put steroid cream on the rash and it did not help.The patient stated they "took benadryl and all it did was put me to sleep".The area still burns and itches though, not as bad as last night.The area where the electrodes were is faint red, the patient not sure what to do.He is very concerned about fusion now that he is not using the bone growth stimulator.The patient used cortizone.The patient does not have sensitive skin.It was later reported that the physician advised the patient to discontinue using the device.No additional patient consequences have been reported.

Manufacturer Narrative

Zimmer biomet complaint# (b)(4).Date of event: the event occurred sometime in (b)(6) 2022.Medical product: unknown.Therapy date: unknown.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device was returned to zimvie for investigation.The reported event was not verifiable after the investigation associated with skin irritation and pain.The device history record was reviewed and no discrepancies related to the reported event were found.No physical and/or functional condition could be found after the dhr that could be considered a causal factor for the reported complaint.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly zimvie will continue to monitor for trends.The following sections have been updated: b4: date of this report added.D3: manufacturer updated.G1: contact office updated.G3: date received by manufacturer added.G6: type of report.H2: follow up type.H3: device evaluated by manufacturer updated to yes.H6: component codes added 451-electrodes.H6: impact code added to 4648 - insufficient information.H6: clinical code added to 2033 - rash.H6: clinical code added to 4545 - skin inflammation/ irritation.H6: clinical code added to 2146 - burning sensation.H6: device code updated to 2682 - patient-device incompatibility.H6: investigation code added to 3331 - analysis of production records.H6: investigation code added to 4119 ¿ insufficient information available.H6: investigation findings code added to 3221- no findings available.H6: investigation conclusions code added to 4315 - cause not established.H10: additional narratives/data.The following sections have been corrected: e1: established name corrected.H6: device code updated to 2993: adverse event without identified device or use problem.

Event Description

It was reported that the patient started using the 72r electrodes for one hour the first day and felt some itching about 3 hours after removing them but couldn't decided if it was dry skin or not.The patient waited until the entire area had cleared up.Yesterday, the patient stated they put the electrodes on for 2 hours.About 2 hours later the area around the where the electrodes were was red and the whole area burned like sunburn and itched like fire.The patient put steroid cream on the rash and it did not help.The patient stated they "took benadryl and all it did was put me to sleep".The area still burns and itches though, not as bad as last night.The area where the electrodes were is faint red, the patient not sure what to do.He is very concerned about fusion now that he is not using the bone growth stimulator.The patient used cortizone.The patient does not have sensitive skin.It was later reported that the physician advised the patient to discontinue using the device.No additional patient consequences have been reported.

• Brand Name: SOFT-TOUCH ELECTRODES, 72R
• Type of Device: STIMULATOR, SPINAL PAK, NON-INVASIVE (72R ELECTRODES)
• Manufacturer (Section D): EBI, LLC.; 1 gatehall dr; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 1 gatehall dr; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 1 gatehall dr; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 13455324
• MDR Text Key: 286350510
• Report Number: 0002242816-2022-00010
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020201
• UDI-Public: 00812301020201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850022/S017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 106130-20
• Device Lot Number: 120801
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 02/04/2022
• Supplement Dates Manufacturer Received: 04/27/2023
• Supplement Dates FDA Received: 05/25/2023
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male