MAUDE Adverse Event Report: EBI, LLC. SPINALPAK ASSEMBLY; STIMULATOR, SPINAL PAK, NON-INVASIVE (SOFT TOUCH ELECTRODES, 63B)

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 07/30/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet (b)(4).Date of event: (b)(6) 2021.Medical product: unknown.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 by the sales rep we have sent her a couple different electrodes and she still continues to break out.Please contact patient with further guidance on other electrodes available and discuss the ramp up schedule for when and how often to wear the spinalpak.Stated that the skin irritation from the 63b electrodes started about 2 weeks ago.The patient did not do the time test.The electrodes are changed every day.The patient only wears the electrodes for about 12 hours a day.The patient is not using the cover patches.63b electrodes lot # 013201.The patient stopped using the electrodes 2 days ago.The skin is red and itchy with little blisters.The patient cleans the area with soap and water.The patient does not have any allergies.The patient takes blood pressure medication.The patient spoke to her doctor.The doctor prescribed betamethasone 0.5% ointment.The doctor told the patient to wait until her skin is clear before starting to use the unit again.The patient will have to do a time test.

Event Description

It was reported by the sales rep we have sent her a couple different electrodes and she still continues to break out.Please contact patient with further guidance on other electrodes available and discuss the ramp up schedule for when and how often to wear the spinalpak.Stated that the skin irritation from the 63b electrodes started about 2 weeks ago.The patient did not do the time test.The electrodes are changed every day.The patient only wears the electrodes for about 12 hours a day.The patient is not using the cover patches.63b electrodes lot # 013201.The patient stopped using the electrodes 2 days ago.The skin is red and itchy with little blisters.The patient cleans the area with soap and water.The patient does not have any allergies.The patient takes blood pressure medication.The patient spoke to her doctor.The doctor prescribed betamethasone 0.5% ointment.The doctor told the patient to wait until her skin is clear before starting to use the unit again.

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: lot number added.D4: unique identifier (udi) number added.G1: contact office updated.G3: date received by manufacturer added.H3: device evaluated by manufacturer updated to yes.H4: device manufacturer date added.H6: component codes added 451-electrodes.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 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, 63B)
• 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: 12366152
• MDR Text Key: 268087639
• Report Number: 0002242816-2021-00152
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00880304820852
• UDI-Public: 00880304820852
• 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: 05/03/2023

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: 013201
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/25/2021
• Supplement Dates Manufacturer Received: 04/11/2023
• Supplement Dates FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2020
• 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 Age: 49 YR
• Patient Sex: Female