MAUDE Adverse Event Report: EBI, LLC. SPINALPAK 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  Death  

Event Description

It was reported that the patient was experiencing a minor skin irritation with the 72r electrodes.The patient advised that her skin was red and itchy, but there were no blisters or welts.The irritation resembled pimples.There was no swelling.The patient advised she changed her electrodes daily and rotated daily.She cleans the area with soap and water in the shower.She does normally have sensitive skin and is sensitive to latex, although allergy testing was negative to latex allergy.Some of her allergies to drugs include: (b)(6).The patient reports no seasonal allergies but allergy testing showed an allergy to english plantain weed.The patient does take a blood pressure medication as a beta-blocker.The patient sought the attention of her surgeon for her irritation, and they suggested rotating the electrodes a little farther apart to give her more rotation locations.The doctor also suggested rubbing (b)(6) on the skin, letting it dry, then placing electrodes on the skin to help protect.It was reported that no further information is available.

Manufacturer Narrative

Zimmer biomet (b)(4).Medical product: unknown.Therapy date: unknown.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient was experiencing a minor skin irritation with the 72r electrodes.The patient advised that her skin was red and itchy, but there were no blisters or welts.The irritation resembled pimples.There was no swelling.The patient advised she changed her electrodes daily and rotated daily.She cleans the area with soap and water in the shower.She does normally have sensitive skin and is sensitive to latex ¿ although allergy testing was negative to latex allergy.Some of her allergies to drugs include cypro, remicade, arava, actimrod, orencia, humira, eggs, adhesive/band aides.The patient reports no seasonal allergies but allergy testing showed an allergy to english plantain weed.The patient does take a blood pressure medication as a beta-blocker.The patient sought the attention of her surgeon for her irritation, and they suggested rotating the electrodes a little farther apart to give her more rotation locations.The doctor also suggested rubbing pepto bismol on the skin, letting it dry, then placing electrodes on the skin to help protect.It was reported that no further information is available.

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.G1: contact office updated.G3: date received by manufacturer added.G6: type of report.H2: follow up type.H3: device evaluated by manufacturer updated to yes.H4: device manufacturer date added.H6: component codes added 451-electrodes.H6: impact code added 4648-insufficient information.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.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: 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: 13255371
• MDR Text Key: 283949547
• Report Number: 0002242816-2022-00002
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2023

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: 118101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 01/13/2022
• Supplement Dates Manufacturer Received: 04/11/2023
• Supplement Dates FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2021
• 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: Female