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

Model Number	FR8A-TRL-A0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Stimwave quality has investigated the details surrounding a complaint resulting from trial device migration reported to stimwave on (b)(4) 2019, by territory manager (b)(4).On (b)(6) 2019, the patient was a recipient of the freedom spinal cord stimulator (scs) system in which two (2) trial leads (fr8a-trl-a0 and fr8a-trl-b0) were implanted in the epidural space to treat patient's chronic lower back pain.There were no complications during the procedure and the patient was discharged the same day.On (b)(6) 2019 the patient returned to the clinic to have the trial devices removed.The implanting clinician reported that he was only able to visualize one (1) out of two (2) leads.The clinician suspected that the second migrated under the skin.Because the trial was successful, the patient elected to have a permanent device implanted the following monday, (b)(6) 2019.The clinician explanted the device that was visible, and determined that he would retrieve the migrated device during the permanent procedure, and the patient consented to this procedure.The patient did not report any adverse effects or injury, and the territory manager reported the trial migration to stimwave on (b)(4) 2019.On (b)(6) 2019, x-rays revealed further device migration.The implanting physician was not available to explant the device, and a neurosurgeon successfully explanted both leads via laminectomy.The patient was discharged from the hospital on (b)(6) 2019 with an unknown prescription for oral antibiotics (name: unknown dose: unknown, duration: unknown).The patient will be implanted with a permanent device on a later date (unknown to stimwave).At the (b)(6) 2019 appointment for trial device removal, the territory manager and clinician reviewed the implantation procedure.The implanting clinician noted that his surgical scrub technician performed the procedure for securing the trial leads.On (b)(6) 2019, the surgical scrub technician affirmed that she understood the procedure, but did not comply with the steps to tie 2-0 non-absorbable suture material around the "nody" of the lead, and ties the lead to the skin using suture material before closing the incision using sterile skin closures and dressed.The implanting clinician confirmed that these steps were not performed as there was no suturing identified on (b)(6) 2019 and one device had migrated cranially from the original placement.Immediately following notification, stimwave quality and management contacted the territory manager to discuss the events leading up to awareness of the issue and to review the implanting clinician's implanting procedural protocol.The territory manager informed stimwave quality and management that the implanting clinician confirmed that surgical scrub technician did not comply with procedures for securing the trial device ((b)(4), page 23, k180981).The patient did not report any other injury or pain as a result of the migration, and is adamant about receiving a permanent device in the near future because of the significant pain relief he experienced during his trial.Stimulator migration is a known adverse event for spinal cord nerve stimulators that is mitigated as far as possible in the product's risk management file.Stimwave believes that if the implanting clinician and team would have followed the ifu, securing the stimulator and anchoring the receiver, this kind of adverse event is less likely to occur.The source of the issue cannot be traced back to the device or the procedure.The device did not fail to meet performance or safety specifications during the procedure.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, nor nonconformance to physical or functional device specifications.The root cause is attributed to the noncompliance to migration mitigation steps detailed in the product's ifu.The stimwave product was not the source of the issue.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 was in constant contact with the territory manager from (b)(4) 2019, onward regarding the complaint and the root cause investigation.Stimwave confirmed that the implant procedure details steps to mitigate migration, and that the product did not fail to meet performance and safety specifications.The source of the issue is attributed to the noncompliance to migration mitigation steps detailed in the product's ifu, and an insufficient suturing technique.Stimwave has informed all parties that the product was not the source of the issue.Stimwave reiterated the steps for the trial instructions for use with the territory manager on (b)(4) 2019.The territory manager affirmed that he would communicate the trial instructions for use steps with the implanting clinician and the surgical scrub technician to ensure that all future cases with the freedom scs system comply with documented implant procedures and migration mitigation steps.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 migration can lead to an injury, and medical or surgical intervention was required to preclude permanent impairment or damage.Stimwave has reported this as an adverse event to the united states food and drug administration (fda) on march 4, 2019.
Event or Problem Description
On (b)(6) 2019, the patient was a recipient of the freedom spinal cord stimulator (scs) system in which two (2) trial leads (fr8a-trl-a0 and fr8a-trl-b0) were implanted in the epidural space to treat patient's chronic lower back pain.There were no complications during the procedure and the patient was discharged the same day.On (b)(6) 2019 the patient returned to the clinic to have the trial devices removed.The implanting clinician reported that he was only able to visualize one (1) out of two (2) leads.The clinician suspected that the second migrated under the skin.Because the trial was successful, the patient elected to have a permanent device implanted the following monday, (b)(6) 2019.The clinician explanted the device that was visible, and determined that he would retrieve the migrated device during the permanent procedure, and the patient consented to this procedure.The patient did not report any adverse effects or injury, and the territory manager reported the trial migration to stimwave on (b)(6) 2019.On (b)(6) 2019, x-rays revealed further device migration.The implanting physician was not available to explant the device, and a neurosurgeon successfully explanted both leads via laminectomy.The patient was discharged from the hospital on (b)(6) 2019 with an unknown prescription for oral antibiotics (name: unknown dose: unknown, duration: unknown).The patient will be implanted with a permanent device on a later date (unknown to stimwave).

• 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: 8388500
• Report Number: 3010676138-2019-00013
• Device Sequence Number: 2051302
• Product Code: GZB
• UDI-Device Identifier: 00818225020679
• UDI-Public: (01)00818225020679(17)201201
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180981
• 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): 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2020
• Device Model Number: FR8A-TRL-A0
• Device Lot Number: SWO181211
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/15/2019
• Device Age: 2 MO
• Event Location: Ambulatory Surgical Facility
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1