MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM SPINAL CORD STIMULATOR

Model Number	FR8A-RCV-A0, FR8A-RCV-B0
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Immediately following notification, stimwave quality reviewed events preceding the issue.The patient had a trial procedure performed on (b)(6) 2016, in which one (1) freedom-8a receiver stimulator (fr8a-rcv-a0) and one (1) spare lead (fr8a-spr-b0) were implanted bilaterally at the t8-t9 vertebral level.The procedure was completed without complications.On (b)(6) 2016, the patient returned to the implanting clinician's office to remove the devices since the trial had concluded.The implanting clinician noticed the proximal end of the devices was no longer visible.The patient had imaging tests performed.The images demonstrated the devices had migrated into the cervical epidural space.The patient was transferred to another hospital to the emergency room for treatment.The patient had a laminectomy performed on (b)(6) 2016 to remove the devices.Following the laminectomy procedure, the patient visited the hospital once again on (b)(6) 2016, due to reports lower back pain.The patient was evaluated and magnetic resonance imaging (mri) was performed.The images showed the patient was experiencing spinal stenosis due to the laminectomy procedure.No further complications related to the device was reported following this visit to the hospital.There was not enough information to identify a root cause for the reported issue.Stimwave is aware the event is a known adverse event.Trial migration is known adverse event of spinal cord stimulation and the freedom scs system and is detailed in stimwave's risk management file as well as applicable instruction for use and patient-facing labeling.Stimwave's global migration rate is <0.5%.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 possible there were external factors that contributed to the issue such as patient compliance and implanting technique.Corrective action is not required to remedy the root cause of the complaint.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 risk management file.Stimwave confirmed that the product did not fail to meet performance and safety specifications.Stimwave confirmed that the implant procedure details steps to mitigate migration, and that the product did not fail to meet performance and safety specifications.Stimwave has informed all parties that the product was not the source 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 the event resulted led to a serious injury.This event has been reported to the united states food and drug administration (fda) on november 21, 2019.
Event or Problem Description
Stimwave quality has investigated the details regarding a complaint resulting from a device migration reported to stimwave on april 4, 2017.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• MDR Report Key: 9356094
• Report Number: 3010676138-2019-00052
• Device Sequence Number: 2648397
• Product Code: GZB
• UDI-Device Identifier: 00859619004875
• UDI-Public: (01)00859619004875(17)180701(01)00859619004882(17)180701(21)STF1000605-17
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/21/2019

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: 07/01/2018
• Device Model Number: FR8A-RCV-A0, FR8A-RCV-B0
• Device Catalogue Number: S8R-1A US
• Device Lot Number: SWL160705A, SWL160705B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2017
• Initial Report FDA Received Date: 11/21/2019
• 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