MAUDE Adverse Event Report: EBI, LLC. SPINALPAK ASSEMBLY; STIMULATOR, SPINALPAK, NONIVASIVE

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Itching Sensation (1943); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 08/10/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (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 patient that she has had skin irritation that started about 3 weeks ago from the 72r electrodes and cover patches on the lumbar area.Skin is red and itchy with draining blisters.The patient changed and rotated the electrodes and cover patches every other day.The patient spoke with her surgeon told her that she can discontinue using the spak any day as it has been 6 months.The patient stated that she did not want to do the time test so she was going to discontinue the usage of the unit.No new products were shipped to the patient.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device was not 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.G1: contact office updated.D4: lot number added.D4: unique identifier (udi) number added.G3: date received by manufacturer added.G6: type of report.H2: follow up type.H3: device evaluated by manufacturer updated to no.H4: device manufacturer date added.H6: component codes added 451 - electrode.H6: component codes added 772 ¿ cover.H6: impact code added 4648-insufficient information.H6: clinical code added 4545 - skin inflammation/ irritation.H6: clinical code added 4537 - blister.H6: clinical code added 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 4114 - device not returned.H6: investigation code added to 4119 ¿ insufficient information available.H6: investigation findings code added to 3221: no findings available.H6: investigation conclusion added to 4315- cause not established.H10: additional narratives/data.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 has had skin irritation that started about 3 weeks ago from the 72r electrodes and cover patches on the lumbar area.Skin is red and itchy with draining blisters.The patient changed and rotated the electrodes and cover patches every other day.The patient spoke with her surgeon told her that she can discontinue using the spak any day as it has been 6 months.The patient stated that she did not want to do the time test so she was going to discontinue the usage of the unit.No new products were shipped to the patient.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: STIMULATOR, SPINALPAK, NONIVASIVE
• 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: 12547119
• MDR Text Key: 273791141
• Report Number: 0002242816-2021-00172
• Device Sequence Number: 1
• Product Code: LOF
• 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: 05/04/2023

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: 103601, 028643
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2021
• Initial Date FDA Received: 09/29/2021
• Supplement Dates Manufacturer Received: 04/11/2023
• Supplement Dates FDA Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2021
• 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