MAUDE Adverse Event Report: EBI, LLC. SPINALPAK ASSEMBLY; STIMULATOR, SPINAL PAK, NON-INVASIVE (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  

Event Description

It was reported that the patient is having a reaction to the 72r electrodes.This reaction occurred months ago, so the patient has not been using her unit for months.The doctor told her to stop using the unit months ago, so she has taken a long break.The skin irritation was around mid-february.The patient stated that her spouse called it scabs on the back of her neck.There were no welts or blisters.The skin irritation was strictly right under the electrodes.The electrodes were changed every day and rotated as well.The patient was wearing the collar at that time.The area was clean with soap and water.No wipes were used.The patient has sensitive skin.The patient does not have allergies, but she does take blood pressure medication.The skin irritation was reported to the surgeon, but she does not know if the sales rep was advised.The patient went to the doctor on (b)(6) 2022 , and that is when she was told to stop using them.Customer service told the patient to do the time test with the 63b electrodes and to call back if she had any issues.No additional patient consequences have been reported.

Manufacturer Narrative

The device was not returned to zimmer biomet 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.Zimmer biomet will continue to monitor for trends.Zimmer biomet complaint cmp(b)(4).Date of event: the event occurred sometime in may 2022.Medical product: unknown.Therapy date: unknown.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: STIMULATOR, SPINAL PAK, NON-INVASIVE (SOFT TOUCH ELECTRODES, 72R)
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 14718617
• MDR Text Key: 294942483
• Report Number: 0002242816-2022-00056
• 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
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• 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: 120801
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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