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 Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2022.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 patient that she is having a skin irritation from the 72r electrodes on the lumbar area.The skin irritation started a few days after she started using them.The skin is red and itchy.The patient stopped using them in (b)(6).The electrodes were changed and rotated every day.The patient used the cover patches, but she does not know if they caused any itchiness.The area is clean with soap, water, alcohol, and baby wipes.The patient has sensitive skin and takes blood pressure medication.The patient does not have any allergies and has not used any new products.The patient called her doctor, who told her to stop using the electrodes.The patient was sent replacement 72r electrodes.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: 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 1943 - 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.The following sections have been corrected: h6: device code updated to 2993: adverse event without identified device or use problem.

Event Description

It was reported by the patient that she is having skin irritation from the 72r electrodes on the lumbar area.The skin irritation started a few days after she started using them.The skin is red and itchy.The patient stopped using them in january or february.The electrodes were changed and rotated every day.The patient used the cover patches, but she does not know if they caused any itchiness.The area is clean with soap, water, alcohol, and baby wipes.The patient has sensitive skin and takes blood pressure medication.The patient does not have any allergies and has not used any new products.The patient called her doctor, who told her to stop using the electrodes.The patient was sent replacement 72r electrodes.No additional patient consequences have been reported.

• 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: 14112669
• MDR Text Key: 289277067
• Report Number: 0002242816-2022-00035
• 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

• Date FDA Received: 04/14/2022
• 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: 112401
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2022
• 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: Female