MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. STIMQ PERIPHERAL NERVE STIMUATOR (PNS) SYSTEM; PERIPHERAL NERVE STIMULATOR

Model Number FR8A-RCV-A0

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 02/15/2019

Event Type  Injury  

Manufacturer Narrative

Stimwave quality has investigated the details surrounding a complaint resulting from an off label device migration that was reported to stimwave on (b)(6) 2019, by stimwave territory manager.On (b)(6) 2019, the territory manager was made aware that a patient's stimulator had migrated caudally from its placement at the back of the skull near the greater occipital nerves intended to treat the patient's chronic migraines.The implanting clinician used x-rays to confirm the migration on (b)(6) 2019.The territory manager was made aware at this appointment that the patient's device was not providing the same amount of pain relief that she was used to experiencing following permanent procedure on (b)(6) 2018.At this appointment, the patient did not report any new pain, other side effects, or injury, thus the implanting clinician recommended that the patient follow up on (b)(6) 2019 to determine the next steps for the device explant or revision.Immediately following notification, stimwave quality and management contacted the clinical specialist to discuss the events leading up to awareness of the issue.The patient was implanted with the stimq peripheral nerve stimulator (pns) system on (b)(6) 2018, in which one (1) freedom-8a receiver stimulators (fr8a-rcv-a0) and one (1) freedom-8a spare lead (fr8a-spr-b0) were implanted off-label at the base of the patient's skull next to the greater occipital nerves to treat the patient's chronic migraines.There were no complications during the procedure.The patient experienced pain relief after the procedure.The territory manager reported that the implanting clinician was aware of the stimq pns system indications for use and the off-label nature of the procedure performed on (b)(6) 2018.Because the procedure was off-label, stimwave could not review the clinician's implantation procedure against the indications for use, but the territory manager was able to recount the implanting clinician's technique on (b)(6) 2018.The implanting clinician made incisions at the base of the patient's skull and advanced the devices cranially to left and right of the midline until the electrodes were next to the greater occipital nerves.He placed sutures for each device at this incision before making a second incision and tunneling the devices to at the back of her neck.The implanting clinician decided to use the sandshark injectable anchor (sia) system off label to anchor the devices at this incision location rather than suture the devices.The implanting clinician made a third incision caudal from the second to suture the proximal ends of the devices.When asked about additional programming sessions with the patient, the territory manager stated that he met with the patient on (b)(6) 2019 at the patient's request re-programming and device evaluation.Reprogramming is an ongoing event comment with neurostimulation.The patient recounted that she had heard a "small pop" on the right side of her head/neck when she looked to the left, and days later experienced the return of her chronic migraines.Following the reprogramming, while the patient did not report any adverse event, injury, illness or deterioration in health, the territory manager advised that the patient may want to consult with her implanting clinician regarding the "small pop" she heard.At the (b)(6) 2019 appointment, when migration was confirmed, the territory manager noted that the device placed right of midline had migrated caudally off the greater occipital nerves to the cervical region.The device placed at left of midline had not migrated and the sandshark anchors and proximal ends had not moved.The territory manager informed stimwave that the implanting clinician suspected that the suture at the base of the skull for the device right of midline may have failed at the same time that the patient heard the "small pop" and that over time, without anchoring, the device migration was experienced.The territory manager confirmed that the implanting clinician was aware that in other pns indications, the stq4 device is used to mitigate migration of the electrodes from nerve targets, however, the implanting clinician reported that he chose to use the fr8a devices for increased coverage to treat the patient's pain.While clinicians are aware that neurostimulators have been used for occipital stimulation, the stimq pns system has not been evaluated for safety and efficacy for occipital placement and treatment of chronic migraines.Because the patient did not report any injury, illness or other adverse event, the implanting clinician recommended that the patient return to the clinic to discuss the next steps for the treatment.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 implanting clinician's noncompliance to device indications for use detailed in the product's instruction for use (ifu, 05-0669-2, page 4, k171366): the stimq peripheral nerve stimulator (pns) system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.The stimq pns system is not intended to treat pain in the craniofacial region.The stimq trial lead kit is only to be used in conjunction with the stimq stimulator receiver kit.The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.The root cause is also likely attributed to suture failure as a result of a mechanical stress (torsion and strain) on the device following the patient's natural physical movements.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 attributed to off-label use and that migration 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.The source of the issue is attributed to the implanting clinician's noncompliance to device indications for use detailed in the product's ifu, and physical stress and strain on the sutures as a result of the patient's movements.Stimwave has informed all parties that the product was not the source of the issue.Stimwave reiterated the stimq indications for use with the territory manager on (b)(4) 2019.The territory manager affirmed that he would communicate the stimq indications for use with the implanting clinician to ensure that all future cases with the stimq pns 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 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) on (b)(4) 2019.

Event Description

On (b)(6) 2019, the territory manager was made aware that a patient's stimulator had migrated caudally from its placement at the back of the skull near the greater occipital nerves intended to treat the patient's chronic migraines.The implanting clinician used x-rays to confirm the migration on (b)(6) 2019.The territory manager was made aware at this appointment that the patient's device was not providing the same amount of pain relief that she was used to experiencing following permanent procedure on (b)(6) 2018.At this appointment, the patient did not report any new pain, other side effects, or injury, thus the implanting clinician recommended that the patient follow up on (b)(6) 2019 to determine the next steps for the device explant or revision.

• Brand Name: STIMQ PERIPHERAL NERVE STIMUATOR (PNS) SYSTEM
• Type of Device: PERIPHERAL NERVE STIMULATOR
• 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: 8367916
• MDR Text Key: 137121783
• Report Number: 3010676138-2019-00010
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00859619004875
• UDI-Public: (01)00859619004875(17)191101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171366
• 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: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2019
• Device Model Number: FR8A-RCV-A0
• Device Catalogue Number: S8R-1A US
• Device Lot Number: SWO171109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/15/2019
• Device Age: 1 YR
• Event Location: Home
• Date Manufacturer Received: 02/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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