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

Model Number	FR8A-RCV-A0, FR8A-SPR-B0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	06/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Stimwave quality has investigated the details from a medwatch report (mw5076893) submitted by a health care professional on april 17, 2018.On may 8, 2019, stimwave became aware of the event upon receipt of the report, which was dated april 17, 2018, by the food and drug administration (fda).The following event description was provided in the medwatch report: stimwave implants movement from its origin site.On (b)(6) 2017, the patient underwent a spinal surgery for placement of stimwave system entered at t12/l1 and t11/t12 levels.This procedure was performed as a treatment for the patient's chronic back pain.Per the surgeon, on (b)(6) during a post-operative check to assess function, the implant was noted on to have moved cephalad - one of the leads.As the lead had moved such that it would possibly require a laminectomy to remove it.On (b)(6) 2017, it was noted to have moved further cephalad.The surgeon stated that she contacted the manufacturer after this occurrence.She was told that they knew about this issue but did not communicate to her in advance.Per the surgeon, so far, 3-4 devices have been implanted and 2 showed this issue.The medwatch report included the event date ((b)(6) 2017), and minimal device identification such as lot numbers, and expiration dates.A nurse completed this report, but this report does not detail if the manufacturer (stimwave) was notified of the event.Stimwave has received one other reported case of elective laminectomy ((b)(4), investigated june 13, 2017).Stimwave reviewed the details of this medwatch report against a similar medwatch report and identified several similarities among (b)(4), (b)(4) (mw5076573), and this complaint (mw5076893): comparator: (b)(4).Medwatch (mw): mw5076573, mw5076893.Implant/ event date: (b)(6) 2017, (b)(6) 2017, (b)(6) 2017.Date of mw report: april 17, 2018, april 17, 2018.Device (identified through stimwave investigation): receiver (fr8a-rcv-a0) and spare (fr8a-spr-b0) stimulators, freedom-8a receiver stimulator kits, receiver (fr8a-rcv-a0) and spare (fr8a-spr-b0) stimulators.Complaint: cranial migration (from t9 to t3/t2), movement cephalad (from t8/t10 or t10/t12 to t3 and lateral), movement cephalad (from t12/l1 or t11/t12 to unspecified location).Remedial action: revision with patient consent for elective laminectomy, if necessary; elective surgery followed by laminectomy; possibility of laminectomy; unconfirmed by reporter.Event description: so far, 3-4 devices have been implanted and 2 showed this issue.Per the surgeon, so far, 3-4 devices have been implanted and 2 showed this issue.Stimwave root cause: attributed to clinician practice and noncompliance to stimwave-issued training and procedure for anchoring stimulators/spare leads and fixating receivers/rf stylet; identical to (b)(4); most likely attributed to clinician practice and noncompliance to stimwave-issued training and procedure for anchoring stimulators/ spare leads and fixating receivers/rf stylet.Based on the above-identified similarities between the medwatch reports, stimwave has determined that both originated from the same implanting clinician.Because (b)(4) was determined to be identical to (b)(4), it is highly likely that the implanting clinician did not comply with stimwave-issued training and procedure for anchoring stimulators/spare leads and fixating receivers/rf stylets on the day of implantation ((b)(6) 2017), which could result in the same remedial action (laminectomy).However, the reporter for this medwatch report does not confirm if a laminectomy was performed, or if the device was explanted.Stimwave has confirmed that the implanting clinician reported the implant procedure as (b)(6) 2017.Contrary to the reporter, stimwave was not made aware of this issue until receipt of the medwatch report from the fda on may 8, 2019; thus, stimwave has not attempted to acquire the devices.If the devices were explanted in 2017, it's highly likely that the devices have been destroyed by the healthcare facility.It is not known if the implanting clinician anchored the device to surrounding tissue as described in the product's instructions for use.It is possible that the patient's activity level may have also contributed to the migration, but adequate anchoring by the clinician during the implantation procedure, as well the use of an anchor would have prevented device migration.The device did not malfunction or operate outside the specification parameters.This is the fourth complaint of stimulator migration requiring potential laminectomy explantation.Stimulator migration is a known adverse event (identified in device product labeling) 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 had followed the ifu to secure the stimulator and anchor 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.The global migration rate for freedom scs system to date is 0.11% (6/5442, instance of migration/total number of cases to date).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.The root cause is attributed to noncompliance to migration mitigation steps detailed in the product's ifu.The stimwave product was not the source of the issue.This is the fourth complaint of stimulator migration with potential laminectomy explantation.As preventative measures through the use of an anchor has been established industry-wide, and documented in product instructions for use, capa is not required to respond to or remedy the root cause of this complaint.The device did not malfunction or operate outside the specification parameters.Stimwave has also designed a deployable anchoring system (sandshark injectable anchor (sia) system), which was cleared for marketing in the united states by the fda (k172644) on november 3, 2017.The sia system eliminates the need to rely on clinician experience for preventing migration.Performance bench testing with this device demonstrates that the sandshark anchor further reduces occurrence of migration.Since market introduction in 2017, when the sia system is used as intended, no migrations with the freedom scs system are reported.(b)(4).Stimwave attempted to contact the implanting clinician, but was unable to establish communication to further investigate the medwatch event reported to stimwave by the fda on may 8, 2019.Based on historical analysis of the implanting clinician's procedure, technique and similar past complaints, the source of the issue is most likely 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.The migration could have been mitigated had the stimulator been implanted in conjunction with an anchoring system.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 may be required to preclude permanent impairment or damage.Stimwave has reported this as an adverse event to the united states food and drug administration (fda).
Event or Problem Description
Stimwave quality has investigated the details from a medwatch report (mw5076893) submitted by a health care professional on april 17, 2018.On may 8, 2019, stimwave became aware of the event upon receipt of the report, which was dated april 17, 2018, by the food and drug administration (fda).The following event description was provided in the medwatch report: stimwave implants movement from its origin site.On (b)(6) 2017, the patient underwent a spinal surgery for placement of stimwave system entered at t12/l1 and t11/t12 levels.This procedure was performed as a treatment for the patient's chronic back pain.Per the surgeon, on (b)(6) during a post-operative check to assess function, the implant was noted on to have moved cephalad - one of the leads.As the lead had moved such that it would possibly require a laminectomy to remove it.On (b)(6) 2017, it was noted to have moved further cephalad.The surgeon stated that she contacted the manufacturer after this occurrence.She was told that they knew about this issue but did not communicate to her in advance.Per the surgeon, so far, 3-4 devices have been implanted and 2 showed this issue.

• 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: 8689511
• Report Number: 3010676138-2019-00023
• Device Sequence Number: 11342710
• Product Code: GZB
• UDI-Device Identifier: 00859619004875
• UDI-Public: (01)00859619004875(17)190101(01)00859619004783(17)190401(21)03508-07
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/10/2019

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: Health Professional
• Device Expiration Date: 01/01/2019
• Device Model Number: FR8A-RCV-A0, FR8A-SPR-B0
• Device Catalogue Number: S8R-1A US
• Device Lot Number: SWO170102;SWO170426
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 2 YR
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 06/11/2019
• 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