MAUDE Adverse Event Report: EBI, LLC. ELECTRODES, LT-4500

Model Number	N/A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Skin Irritation (2076); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint: (b)(4).Medical product: spinal pak assembly; catalog: 1067716; serial#:(b)(4).Therapy date: unknown.Medical product: 4.5 x 22 infinity pedicle screws at c7.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 or Problem Description
It was reported that the patient developed skin irritation from all 3 types of the electrodes; the lt-4500 electrodes, the 72r electrodes, and the 63b.The patient had a rash.The described her skin as red and itchy with bumps and welts.The patient wore the 63b electrodes and after 5 hours her became red and itchy.She waited for the skin to heal.The tried the lt-4500 electrodes and after 6 hours her skin became red and itchy.The patient reported that she has sensitive skin.The patient contacted her doctor and was advised to discontinue treatment.It was reported that no further information is available.
Event or Problem Description
It was reported that the patient developed skin irritation from all 3 types of the electrodes; the lt-4500 electrodes, the 72r electrodes, and the 63b.The patient had a rash.The described her skin as red and itchy with bumps and welts.The patient wore the 63b electrodes and after 5 hours her became red and itchy.She waited for the skin to heal.The tried the lt-4500 electrodes and after 6 hours her skin became red and itchy.The patient reported that she has sensitive skin.The patient contacted her doctor and was advised to discontinue treatment.It was reported that no further information is available.
Additional 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.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.

• Brand Name: ELECTRODES, LT-4500
• Common Device Name: 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: 10687783
• Report Number: 0002242816-2020-00106
• Device Sequence Number: 3110618
• Product Code: LOF
• UDI-Device Identifier: 00812301020188
• UDI-Public: 00812301020188
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P850022/S017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 106130-12
• Device Lot Number: 916515
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female