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

Model Number N/A

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Zimvie 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 zimvie for investigation.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.

Event Description

Reaction to 72r electrodes.It was reported the patient had a reaction to the 72r electrodes.He had blisters on his skin for the first time 6 weeks into him using the device.The patient stated that the skin irritation is on the cervical area from the 72r electrodes.The skin irritation started 8 weeks after he started using the spinal pak device.The patient has not done anything differently.The patient describes the skin as red and itchy with small blisters.There is no swelling.The skin irritation is under the electrodes.The patient used rubbing alcohol and neosporin ointment.The patient changes the electrodes every day.The electrodes are not moved around.The area is clean with soap and water and does not use wipes.The patient does not have sensitive skin or allergies.No new product.No blood pressure medication.The patient showed the skin irritation to the doctor.The doctor thought it was a reaction of the gel.It was later reported on (b)(6) 2022, the patient stated that he talked to the nurse practitioner at his doctor's office who told him to stop using the unit and recommended he use an over-the-counter ointment on the irritation.No additional patient consequences have been reported.

Event Description

Reaction to 72r electrodes.It was reported the patient had a reaction to the 72r electrodes.He had blisters on his skin for the first time 6 weeks into him using the device.The patient stated that the skin irritation is on the cervical area from the 72r electrodes.The skin irritation started 8 weeks after he started using the spinal pak device.The patient has not done anything differently.The patient describes the skin as red and itchy with small blisters.There is no swelling.The skin irritation is under the electrodes.The patient used rubbing alcohol and neosporin ointment.The patient changes the electrodes every day.The electrodes are not moved around.The area is clean with soap and water and does not use wipes.The patient does not have sensitive skin or allergies.No new product.No blood pressure medication.The patient showed the skin irritation to the doctor.The doctor thought it was a reaction of the gel.It was later reported on aug 1, 2022, the patient stated that he talked to the nurse practitioner at his doctor's office who told him to stop using the unit and recommended he use an over-the-counter ointment on the irritation.No additional patient consequences have been reported.

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.The following sections have been updated: b4: date of this report added.D3: manufacturer updated.D4: unique identifier (udi) number added.G1: contact office updated.G3: date received by manufacturer added.G6: type of report updated.H2: follow up type updated.H3: device evaluated by manufacturer updated to yes.H4: device manufacturer date added.H6: component codes added 451-electrodes.H6: impact code added to 4648 - insufficient information.H6: clinical code added to 4545 - skin inflammation/ irritation.H6: clinical code added to 1907 - hypersensitivity/allergic reaction.H6: clinical code added to 2033 - rash.H6: clinical code added to 4537 - blister.H6: clinical code added to1943 - itching 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: h6: device code updated to 2993: adverse event without identified device or use problem.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: STIMULATOR, SPINAL PAK, NON-INVASIVE (SOFT TOUCH ELECTRODES, 72R)
• 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: 15331645
• MDR Text Key: 299039491
• Report Number: 0002242816-2022-00103
• 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: 120801
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 08/31/2022
• Supplement Dates Manufacturer Received: 04/04/2023
• Supplement Dates FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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: Male