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

Model Number N/A

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The event occurred sometime in (b)(6) 2021.Concomitant products & therapy dates: medication: hydrocodone-acetaminophen 10-325 mg, medication: sennosides 8.6 mg, medication: tizanidine hcl 4 mg, medication: gabapentin 60mg, medication: duloxeline hcl 30 mg, medication: diazinepam 10mg, 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 a bad irritation while using the 72r electrodes.The patient wore the electrodes 24/7 and changed them every two days because they would become slim.The patient says that he wears the electrodes on his neck with the cover patches and rotates them after a day or two.The patient has not worn the electrodes in 3 days because of soreness.The patient says that her does not have sensitive skin.The patient saw his doctor who suggested to apply hydrocortisone.Zimmer biomet sent the patient replacement 63b electrodes.He discarded the 72r electrodes.New 63b electrodes were shipped to the patient.

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

It was reported that the patient experienced a bad irritation while using the 72r electrodes.The patient wore the electrodes 24/7 and changed them every two days because they would become slim.The patient says that he wears the electrodes on his neck with the cover patches and rotates them after a day or two.The patient has not worn the electrodes in 3 days because of soreness.The patient says that her does not have sensitive skin.The patient saw his doctor who suggested to apply hydrocortisone.Zimmer biomet sent the patient replacement 63b electrodes.He discarded the 72r electrodes.New 63b electrodes were shipped to the patient.

• Brand Name: SPINAL PAK ASSEMBLY
• Type of Device: SPINAL PAK NON-INVASIVE STIMULATOR (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: 12476982
• MDR Text Key: 271583366
• Report Number: 0002242816-2021-00169
• 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: 02/08/2023

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: 106701
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/15/2021
• Supplement Dates Manufacturer Received: 08/30/2021
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• 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