MAUDE Adverse Event Report: EBI, LLC. SPINALPAK ASSEMBLY; SPINAL PAK NON-INVASIVE STIMULATOR (SOFT TOUCH ELECTRODES, 72R)

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Skin Inflammation/ Irritation (4545); Contact Dermatitis (4546)

Event Date 09/08/2021

Event Type  Injury  

Event Description

It was reported by the sales rep that the patient is have a skin irritation from the 72r electrodes.Patient described it as contact dermatitis.Patient stated that she broke out in red irritated patches, strictly under the 72r electrodes, no covers.Patient wore them 24/7 except for showering.Patient rotated and changed once a day.The itching was bad.Patient saw her doctor who stated she has contact dermatitis.Doctor prescribed steroid ointment.Sending 63b electrodes and the patient will conduct a timed test.New 63b electrodes were shipped to the patient.Update: patient has sensitive skin.

Manufacturer Narrative

(b)(4).Date of event: (b)(6) 2021.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 sales rep that the patient is have a skin irritation from the 72r electrodes.Patient described it as contact dermatitis.Patient stated that she broke out in red irritated patches, strictly under the 72r electrodes, no covers.Patient wore them 24/7 except for showering.Patient rotated and changed once a day.The itching was bad.Patient saw her doctor who stated she has contact dermatitis.Doctor prescribed steroid ointment.Sending 63b electrodes and the patient will conduct a timed test.New 63b electrodes were shipped to the patient.Update: patient has sensitive skin.

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: b4: date of this report added.D2 type of device added.D3: manufacturer updated.D4:additional information lot number added.D4: additional information unique identifier (udi) number updated.G1-2: contact office updated.G3: date received by manufacturer updated.H6: component codes added 451-electrodes.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.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: SPINAL PAK NON-INVASIVE STIMULATOR (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: 12577291
• MDR Text Key: 281078560
• Report Number: 0002242816-2021-00176
• 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: 10/18/2022

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: 112401
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 10/05/2021
• Supplement Dates Manufacturer Received: 09/20/2022
• Supplement Dates FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female