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

Model Number	FR8A-TRL-A0, FR8A-TRL-B0
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Immediately following notification, stimwave quality and the territory manager reviewed events preceding the issue.The patient had a trial procedure performed on (b)(6) 2019, in which two freedom-8a trial leads (fr8a-trl-a0, fr8a-trl-b0) were implanted bilaterally at the t12-l1vertebral level for lower back pain.The territory manager confirmed that the implant procedure was performed in a sterile environment, sterile field handling protocols were used, the procedure was completed in accordance with the product instructions for use, and the sterile barriers of all product used were intact prior to implant.The procedure was completed without complication, and the territory manager maintained contact with the patient following implant.On (b)(6) 2019, the patient visited the implanting clinician's office to remove the devices, since they had reached the end of the trial.The patient reported they were experiencing diminished pain relief, compared to the beginning of the trial.The implanting clinician decided to perform imaging tests in order to visualize the location of the devices.The images showed the patient's devices had migrated further up and into the epidural space.The implanting clinician scheduled an explant procedure for the following day.On (b)(6) 2019, the implanting clinician performed the explant procedure and was able to remove one of the devices.However, the remaining device was fully into the epidural space and could not be accessed by the implanting clinician.The implanting clinician believed laminectomy was the best option for the patient.The patient's cardiologist notified the implanting clinician that the patient was not a candidate for general anesthesia.The implanting clinician decided to evaluate the patient for general anesthesia before preforming any other remedial actions.The instructions for use details steps to mitigate migration.The territory manager reported the implanting clinician placed securing bandages over the stimulator.However, the territory manager reported the patient applied too much stress on their back when leaning into their reclining chair.It is possible the stress caused the devices to migrated further up and into the epidural space.As of (b)(6) 2019, no further complications have been reported.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.The stimwave product was not the source of the issue.The root cause is attributed to the stress applied to the location of the devices.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 loss of therapy is known potential issue and is mitigated as far as possible.Stimwave will continue to track and trend stimwave was in constant contact with the territory manager from october 21, 2019, onward regarding the complaint and the root cause investigation.The source of the issue is attributed to patient non-compliance.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 this event required medical intervention by a health care professional to prevent or preclude potential permanent impairment or damage.Stimwave reported this issue to the united states food and drug administration (fda) on november 15, 2019.
Event or Problem Description
Stimwave quality has investigated the details regarding a complaint resulting from trial device migration reported to stimwave on october 21, 2019.

• 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: 9331973
• Report Number: 3010676138-2019-00049
• Device Sequence Number: 1849266
• Product Code: GZB
• UDI-Device Identifier: 00818225020679
• UDI-Public: (01)00818225020679(17)210801(01)00818225020662(17)200901(21)209072-6
• 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): 11/15/2019

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: 08/01/2021
• Device Model Number: FR8A-TRL-A0, FR8A-TRL-B0
• Device Lot Number: SWO190815, SWO180921
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 11/15/2019
• 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