MAUDE Adverse Event Report: EBI, LLC. SPINALPAK ASSEMBLY; 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 Itching Sensation (1943); Rash (2033); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2021.Surgical procedures: posterior lumbar fusion using bilateral peek expandable grafts with interbody arthrodesis l4-l5, l5-s1 performed on (b)(6) 2021.Medical product: pedicle screws.Medical product: pedicle rod.Medical product: biomet polaris t.Therapy date: unknown.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient experienced skin irritation while using the 72r electrodes.The irritation started (b)(6) 2021, the skin was itchy and red, there were blisters and welts, with no swelling.The patient does not have sensitive skin.The patient had lupus, erythromycin, and naprosyn.The patient contacted the doctor in (b)(6) 2021 and informed him of the irritation.The doctor advised to take off the electrodes for few days and try again with the treatment.It was reported in (b)(6) 2021 that the patient is having an allergic reaction to the 72r electrodes and does not appear to be able to wear the unit due to skin irritation.The patient later reported that she started having issues with the 63b electrodes after wearing them for 4 hrs.The patient said that she could not use the unit at all.The patient had confirmed, in (b)(6) 2021, that the doctor was not happy that the 63b electrodes (and 72r electrodes) caused irritation and blisters.The doctor decided that it was best to stop treatment.

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.

Event Description

T was reported that the patient experienced skin irritation while using the 72r electrodes.The irritation started (b)(6) 2021, the skin was itchy and red, there were blisters and welts, with no swelling.The patient does not have sensitive skin.The patient had lupus, erythromycin, and naprosyn.The patient contacted the doctor in (b)(6) 2021 and informed him of the irritation.The doctor advised to take off the electrodes for few days and try again with the treatment.It was reported in april 2021 that the patient is having an allergic reaction to the 72r electrodes and does not appear to be able to wear the unit due to skin irritation.The patient later reported that she started having issues with the 63b electrodes after wearing them for 4 hrs.The patient said that she could not use the unit at all.The patient had confirmed, in (b)(6) 2021, that the doctor was not happy that the 63b electrodes (and 72r electrodes) caused irritation and blisters.The doctor decided that it was best to stop treatment.

• Brand Name: SPINALPAK ASSEMBLY
• 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: 12326967
• MDR Text Key: 267278600
• Report Number: 0002242816-2021-00139
• 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
• 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: 04/10/2023

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: 1067716
• Device Lot Number: 020701
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/02/2021
• Initial Date FDA Received: 08/16/2021
• Supplement Dates Manufacturer Received: 04/04/2023
• Supplement Dates FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2020
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention
• Patient Sex: Female