MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM

Model Number	FR8A-TRL-A0, FR8A-TRL-B0
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Stimwave quality has investigated the details regarding a trial device migration reported to stimwave on (b)(6) 2019, by territory manager (b)(4) and clinical specialist (b)(4).The patient had a temporary trial procedure placing two (2) freedom 8 trial leads (fr8a-trl-a0 and fr8a-trl-b0) epidurally and externalized on (b)(6) 2019.On (b)(6) 2019, the patient met with the clinician and territory manager for post-operative follow-up evaluation and reprogramming.The wound dressing was found to have peeled back and detached from the skin.The fr8a-trl-b0 device was pulled out at this visit, but the fr8a-trl-a0 device tail was no longer visible outside the skin.An x-ray confirmed that the device had migrated cephalad to the c2 vertebra.On (b)(6) 2019, a neurosurgeon explanted the device via a laminectomy without complication.The patient reported to be in good health on (b)(6) 2019, and has reported no new issues.The clinical specialist reported that the clinician sutured around each externalized device to the patient's skin at the needle entry site with a 2.0 silk suture via the chest tube method.The clinical specialist reported that the clinician tied the end of the leads together and then requested the surgical scrub technician dress the implant site by placing steri-strips over the externalized tubing in a linear fashion, two (2) tegaderm dressings, and medipore tape.This deviates from the recommended crossed chevron steri-strip pattern and the use of liquid medical adhesive.The patient reported following all post-operative care instructions with no unusual incidents.Device migration is a known adverse event for spinal cord stimulators mitigated in the product risk management file.Per protocol, trial devices are not anchored and have a higher likelihood of migrating if the patient is active and/or the suture and wound dressing technique used to secure the device(s) is inadequate or becomes detached.Given the provided information, the source of the issue cannot be traced back to the device or the procedure.Stimwave reviewed the events of the trial procedure, and while the clinician took measures to secure the device, it is not known if measures were taken to prevent device movement.The patient confirmed compliance with post-operative instructions, but it is not known if other uncontrollable factors may have caused or contributed to the issue.Stimwave will continue to track and trend events.The root cause of the complaint is not attributed to device failure, the inability of the device to meet performance or safety specifications, or nonconformance to physical or functional device specifications.It is likely that inadvertent noncompliance to the product's instructions for use and/or post-operative care contributed to the event.Given the information provided to during the investigation, stimwave is unable to identify a single event that caused or contributed to the event.Corrective action is not required to remedy the root cause of the complaint, as the device did not fail to meet performance or safety specifications.Stimwave has confirmed that the issue is a known adverse event, mitigated as far as possible, and documented in the stimwave's risk management file.Stimwave's global migration rate is (b)(4), and occurrence of migration resulting in surgical intervention for the freedom scs system is very low, (b)(4) (or (b)(4), instance of migration with laminectomy/total number of cases to date).Stimwave was in constant contact with the territory manager and clinical specialist from (b)(4) 2019, onward regarding the complaint and the root cause investigation.Stimwave has informed all parties that the product was not the source of the issue.In compliance with medical device reporting requirements and responsibilities, stimwave quality and its chief medical officer have determined that this issue is considered reportable as this event required surgical intervention to prevent or preclude potential permanent impairment or damage.Stimwave has reported this as an adverse event to the united states food and drug administration (fda) on june 19, 2019.
Event or Problem Description
The patient had a temporary trial procedure placing two (2) freedom 8 trial leads (fr8a-trl-a0 and fr8a-trl-b0) epidurally and externalized on (b)(6) 2019.On (b)(6) 2019, the patient met with the clinician and territory manager for post-operative follow-up evaluation and reprogramming.The wound dressing was found to have peeled back and detached from the skin.The fr8a-trl-b0 device was pulled out at this visit, but the fr8a-trl-a0 device tail was no longer visible outside the skin.An x-ray confirmed that the device had migrated cephalad to the c2 vertebra.On (b)(6) 2019, a neurosurgeon explanted the device via a laminectomy without complication.The patient reported to be in good health on (b)(6) 2019, and has reported no new issues.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• MDR Report Key: 8711749
• Report Number: 3010676138-2019-00025
• Device Sequence Number: 2600645
• Product Code: GZB
• UDI-Device Identifier: 00818225020679
• UDI-Public: (01)00818225020679(17)201201(01)00818225020662(17)210201(21)209657-18
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K182720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/19/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/01/2020
• Device Model Number: FR8A-TRL-A0, FR8A-TRL-B0
• Device Lot Number: SWO181211, SWO190202
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/24/2019
• Device Age: 6 MO
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention