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

Model Number FR8A-TRL-A0, FR8A-TRL-B0, FR8A-RCV-A0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 01/15/2019

Event Type  Injury  

Manufacturer Narrative

Stimwave quality has investigated the details surrounding a complaint resulting from a migration reported to stimwave on (b)(4) 2019, by stimwave territory manager (b)(4).The patient was implanted with the freedom scs system trial devices (fr8a-trl-a0 and fr8a-trl-b0) on (b)(6) 2018 in the epidural space at the t8 to t9 level to determine if spinal cord stimulation will effectively treat the patient's failed back surgery syndrome (fbss).On (b)(6) 2018, the patient returned to have the trial devices removed.The clinician noted that the patient had replaced the bandages he placed on the day of the trial.The clinician was able to remove one trial device, but was not able to locate the second.The therapy manager recommended using fluoroscopy to locate the second device as it may have migrated.The clinician expressed that he believed the device to have been removed inadvertently by the patient when the bandaging was changed.However, fluoroscopic imaging of the patient's thoracic region did not reveal the second device.The patient stated that he received at least 50% reduction in his pain during the trial, and thus, was scheduled for a permanent procedure with a different clinician.On (b)(6) 2018, a receiver stimulator (fr8a-rcv-a0) and spare lead (fr8a-spr-b0) was implanted in the epidural space at the t8 to t9 level to treat the patient's failed back surgery syndrome (fbss).No complications occurred during the procedure, and the patient received pain relief comparable to that of the trial.On (b)(6) 2019, the patient reported experiencing some neck pain and followed up with the clinician who implanted the trial devices for a physical examination.An x-ray revealed two migrated devices; one at c1 and another at c5.The patient informed the clinician that he was continuing to receive good coverage and pain relief with the freedom scs system.The patient followed up with the clinician and the territory manager who performed the permanent procedure on (b)(6) 2019 for evaluation and device revision planning.The patient did not report any other issues with the system or complaints other than the neck pain, but continued to receive pain relief with their device.On (b)(6) 2019, the clinician who performed the permanent implant was scheduled to complete the device explant.During the procedure, fluoroscopy was used to visualize the migrated devices.The implanting clinician observed the two devices in the cervical region, and one device in the thoracic region.The territory manager and the clinician concluded that one of the devices in the cervical region was the trial device that had migrated and the spare lead (fr8a-spr-b0) from the permanent procedure.The receiver stimulator had not migrated, but remained at the permanent placement.The clinician had explanted all devices without complication.Immediately following notification of the issue by the territory manager on (b)(4) 2019, stimwave quality and management reviewed the events following the procedure leading up to device explant.For the trial procedure, the territory manager confirmed that the implanting clinician complied with the all steps of the trial instructions for use.The territory manager stated that the implanting clinician for the trial device was unable to locate the second trial device with fluoroscopy and presumed that the patient mistakenly removed the device during the bandage.Stimwave quality, stimwave management, and the territory manager reviewed the implanting clinician's procedure for the permanent devices compared to the electrode array instructions for use (ifu) receiver ifu.The procedure for anchoring the stimulator (electrode array ifu) instructs clinicians to employ the use of the sandshark injectable anchor (sia) system to secure the device beneath the fascia and anterior to the ligamentum flavum (05-00762-1, page 21, k180981).The territory manager informed stimwave that this step was not followed, as the sia system was not available at the time of the procedure.Stimwave asked if the clinician placed a suture at the location where the sandshark anchor would have been deployed if used, and the territory manager reported that a suture was placed to secure the stimulator to the surrounding tissue.The procedure for coil and fixate the receiver (receiver ifu) instructs clinicians to tie a knot using the remaining receiver tubing, and coil the remaining tubing into a 3cm diameter coil and tie a square knot around the coil and into the fascia at three locations and at the marker band (05-00629-5, page 19, k180981).The territory manager informed stimwave that he could not verify that this step was followed, though at the explant procedure, a coil was not identified for the receiver stimulator that had not migrated.The source of the issue was not traced back to inadequate documentation of implant procedure, and the device did not fail to meet performance or safety specifications.Stimulator migration is a known adverse event for spinal cord stimulators and the freedom scs system and is mitigated as far as possible in the product's risk management file.Stimwave believes that if the implanting clinician had followed the ifu, anchoring the stimulator and coiling and fixating the receiver, this kind of adverse event is less likely to occur.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 implanting clinician's noncompliance to migration mitigation steps detailed in the product's ifu, and insufficient suturing technique.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's risk management file.Stimwave was in constant contact with the territory manager from (b)(4) 2019 and onward regarding the complaint and the root cause investigation.Stimwave confirmed that the implant procedure details steps to mitigate migration, and the product did not fail to meet performance and safety specifications.The source of the issue is attributed to the implanting clinician's noncompliance to migration mitigation steps detailed in the product's ifu, and insufficient suturing technique.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 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.

Event Description

On (b)(6) 2019, the patient reported experiencing some neck pain and followed up with the clinician who implanted the trial devices for a physical examination.An x-ray revealed two migrated devices; one at c1 and another at c5.The patient informed the clinician that he was continuing to receive good coverage and pain relief with the freedom scs system.The patient followed up with the clinician and the territory manager who performed the permanent procedure on (b)(6) 2019 for evaluation and device revision planning.The patient did not report any other issues with the system or complaints other than the neck pain, but continued to receive pain relief with their device.On (b)(6) 2019, the clinician who performed the permanent implant was scheduled to complete the device explant.During the procedure, fluoroscopy was used to visualize the migrated devices.The implanting clinician observed the two devices in the cervical region, and one device in the thoracic region.The territory manager and the clinician concluded that one of the devices in the cervical region was the trial device that had migrated and the spare lead (fr8a-spr-b0) from the permanent procedure.The receiver stimulator had not migrated, but remained at the permanent placement.The clinician had explanted all devices without complication.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
• Type of Device: SPINAL CORD STIMUATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer Contact: elizabeth greene ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 8281707
• MDR Text Key: 134227730
• Report Number: 3010676138-2019-00002
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020679
• UDI-Public: (01)00818225020679(17)200401(01)00818225020662(17)200301(21)207909-76;(01)00859619004875(17)191001(21)26907-77
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2019
• Device Model Number: FR8A-TRL-A0, FR8A-TRL-B0, FR8A-RCV-A0
• Device Lot Number: SWO180417,SWO180312,SWO171024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/16/2019
• Device Age: 15 MO
• Event Location: Home
• Date Manufacturer Received: 01/16/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention