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 Itching Sensation (1943); Pain (1994); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

It was reported by the patient that she is having irritation with the 72r electrodes.The patient claims her skin was red, itchy, and painful.The patient rated her pain as an 8 on a scale of 1 to 10, which is considered severe.The patient claims that she took pain meds to manage the pain.The pain was on the surface of her skin, as well as beneath the surface.The patient has many allergies -- iodine, albuterol, foods, broccoli, perkaset, obiata, glues, milk, cad, perfumes, etc.She has a heart condition and is sensitive to surgical tapes and glues.The patient has seasonal allergies and takes blood pressure medication.The patient called the surgeon's office and spoke with the doctor's rep, erin benard, and she said to call zimvie for advice.The patient agrees to perform a time test with the new usa 72r electrodes, and she will return an example of the old 72r electrodes.Customer service is sending both usa 72rs and 63b electrodes.She will try the 72r electrodes first, then the 63bs if they do not agree with her.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 zimvie 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.

Event Description

It was reported by the patient that she is having irritation with the 72r electrodes.The patient claims her skin was red, itchy, and painful.The patient rated her pain as an 8 on a scale of 1 to 10, which is considered severe the patient claims that she took pain meds to manage the pain.The pain was on the surface of her skin, as well as beneath the surface.The patient has many allergies -- iodine, albuterol, foods, broccoli, perkaset, obiata, glues, milk, cad, perfumes, etc.She has a heart condition and is sensitive to surgical tapes and glues.The patient has seasonal allergies and takes blood pressure medication.The patient called the surgeon's office and spoke with the doctor's rep, erin benard, and she said to call zimvie for advice.The patient agrees to perform a time test with the new usa 72r electrodes, and she will return an example of the old 72r electrodes.Customer service is sending both usa 72rs and 63b electrodes.She will try the 72r electrodes first, then the 63bs if they do not agree with her.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: 15008348
• MDR Text Key: 295862415
• Report Number: 0002242816-2022-00070
• 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: 05/10/2023

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: 108101
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 07/13/2022
• Supplement Dates Manufacturer Received: 04/19/2023
• Supplement Dates FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• 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