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 Burn(s) (1757); Pain (1994); 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.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 that the unit has burned the patient 3 times now (causing blistering and blood) and is extremely painful to use as it burns me.This has happened 3 times already and it typically happens between 36 and 48 hours of use before changing pads.Later, it was reported that the patient developed a rash while using the 72r electrodes.The patient changed the electrodes every 48 hours and rotated the position on his skin.The patient wears the electrodes on his lower back l4-l4.The patient cleans the area with soap and water.He spoke to his doctor and was told maybe comes from the unit or electrodes.The doctor would like for him to replace the unit and electrodes.Zimmer biomet advised the patient to take a break in treatment with the unit until his skin is completely healed then conduct a time test at 1 hour increments starting with the 63b electrodes.Zimmer biomet also discussed changing the position of electrodes each day.The patient was shipped a replacement spinal pak controller and soft touch electrodes, 63b.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, burns, and rash.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.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 to 4648 - insufficient information.H6: clinical code added to 4545 - skin inflammation/ irritation.H6: clinical code added to 1994 - pain.H6: clinical code added to 1757- burn(s).H6: clinical code added to 4537 - blister.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.D5: operator of device updated.

Event Description

It was reported that the unit has burned the patient 3 times now (causing blistering and blood) and is extremely painful to use as it burns me.This has happened 3 times already and it typically happens between 36 and 48 hours of use before changing pads.Later, it was reported that the patient developed a rash while using the 72r electrodes.The patient changed the electrodes every 48 hours and rotated the position on his skin.The patient wears the electrodes on his lower back l4-l4.The patient cleans the area with soap and water.He spoke to his doctor and was told maybe comes from the unit or electrodes.The doctor would like for him to replace the unit and electrodes.Zimmer biomet advised the patient to take a break in treatment with the unit until his skin is completely healed then conduct a time test at 1 hour increments starting with the 63b electrodes.Zimmer biomet also discussed changing the position of electrodes each day.The patient was shipped a replacement spinal pak controller and soft touch electrodes, 63b.It was reported that no further information is available.

• 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: 12254899
• MDR Text Key: 264471817
• Report Number: 0002242816-2021-00130
• 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: 03/21/2023

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: 103601
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/09/2021
• Initial Date FDA Received: 07/30/2021
• Supplement Dates Manufacturer Received: 02/28/2023
• Supplement Dates FDA Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male