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 Problems Pain (1994); Rash (2033); Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

It was reported that the patient had a rash where the 72r electrodes were.The patient claimed his skin was red, swollen, and itchy but he had no blisters or welts.The patient stated that the irritation was under the electrodes.The patient stated that he changes the electrodes every day and a half and rotates them slightly when changing.The patient claimed he cleans with soap, water, and a scrub brush in the shower.The patient claimed he has sensitive skin, an allergy to benadryl and seasonal allergies.The patient reported that he does not take blood pressure medication.The patient stated that he spoke with his surgeon who suggested for the patient to pause treatment until the skin clears and call customer service for advice.The patient will perform the time test with the 63b electrodes and will return an example of the 72r electrodes.It was later reported by the patient on (b)(6) 2022, that he did not speak to any medical professional about his irritation other than his conversation with the surgeon advising him to pause treatment and contact the zimvie sales representative.The patient claims his skin was burned and red after 5 to 10 seconds on the skin.The spinal pak was not connected to the electrodes at the time.The patient rated her pain as a 10 on a scale of 1 to 10, which is considered severe, and the burning sensation was shocking and painful.The patient removed the electrodes immediately and cleansed the skin with cold water and eventually soap and water.The patient reports welts on the skin.No blisters and no itchiness.Irritation was directly under the electrodes, and the patient did not have an opportunity to rotate.He will not rotate in the future.The patient has sensitive skin.The patient reports an allergy to benadryl.He has seasonal allergies and also has asthma.He does not take blood pressure medication and has not used any creams.It was reported that no further information is available.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2022.Medical product: unknown.Therapy date: unknown.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.

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 corrected: h6: device code updated to 2993: adverse event without identified device or use problem.

Event Description

It was reported that the patient had a rash where the 72r electrodes were.The patient claimed his skin was red, swollen, and itchy but he had no blisters or welts.The patient stated that the irritation was under the electrodes.The patient stated that he changes the electrodes every day and a half and rotates them slightly when changing.The patient claimed he cleans with soap, water, and a scrub brush in the shower.The patient claimed he has sensitive skin, an allergy to benadryl and seasonal allergies.The patient reported that he does not take blood pressure medication.The patient stated that he spoke with his surgeon who suggested for the patient to pause treatment until the skin clears and call customer service for advice.The patient will perform the time test with the 63b electrodes and will return an example of the 72r electrodes.It was later reported by the patient on (b)(6) 2022, that he did not speak to any medical professional about his irritation other than his conversation with the surgeon advising him to pause treatment and contact the zimvie sales representative.The patient claims his skin was burned and red after 5 to 10 seconds on the skin.The spinal pak was not connected to the electrodes at the time.The patient rated her pain as a 10 on a scale of 1 to 10, which is considered severe, and the burning sensation was shocking and painful.The patient removed the electrodes immediately and cleansed the skin with cold water and eventually soap and water.The patient reports welts on the skin.No blisters and no itchiness.Irritation was directly under the electrodes, and the patient did not have an opportunity to rotate.He will not rotate in the future.The patient has sensitive skin.The patient reports an allergy to benadryl.He has seasonal allergies and also has asthma.He does not take blood pressure medication and has not used any creams.It was reported that no further information is available.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: STIMULATOR, SPINAL PAK, NON-INVASIVE (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: 15168584
• MDR Text Key: 297315441
• Report Number: 0002242816-2022-00080
• 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: 09/09/2022

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: 204202
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 08/04/2022
• Supplement Dates Manufacturer Received: 06/15/2022
• Supplement Dates FDA Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2022
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention
• Patient Sex: Male