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

Model Number STQ4-RCV-A0, STQ4-SPR-B0

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

Patient Problem No Code Available (3191)

Event Date 03/01/2019

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 march 4, 2019, by stimwave distributor.On (b)(6) 2019 the distributor was made aware that the patient's stimulator had migrated superior towards the neck and one caudally under the arm/torso.The clinician used x-rays to confirm that the patient's device migrated on (b)(6) 2019.At this appointment, the patient did not report any new pain, other side effects, or injury.The distributor was made aware at this appointment that device was no longer in the original implanted location.Immediately following notification, stimwave quality and management contacted the distributor to discuss the events leading up to awareness of the issue.The patient was implanted with stimq peripheral nerve stimulator (pns) system on (b)(6) 2018, in which one (1) stimq receiver stimulators (stq4-rcv-a0) and one (1) stimq spare lead (stq4-spr-b0) were implanted next to the supra-scapular nerves in her the left shoulder to treat patient's chronic shoulder and supra-scapular pain.There were no complications during the procedure.The patient was non-responding or communicating with the distributor or the implanting clinician after procedure.Both the distributor and the healthcare facility attempted to contact the patient for follow-up but were unable to establish communication.Thus, the patient missed several appointments with implanting clinician to establish follow up care.The implanting physician closed his practice on (b)(6) 2018, and the distributor became aware that patient care was transferred to another practice, but this practice also reported that the patient would miss appointments for follow-up.On (b)(6) 2019 the patient attended a follow-up appointment with the new clinician and the distributor.An x-ray determined devices migrated off the target nerves, one device was visualized in the patient's neck, the other device was observed under the patient's arm.The treating clinician discussed the options for device revision with the patient, but the patient elected for device explant.A procedure date has not been scheduled.Stimwave quality reviewed the steps taken by the implanting clinician during the permanent procedure with the distributor.The distributor reported that implanting clinician placed the devices with the electrodes at the supra-scapular nerves, and the receivers tunneled down the arm.Both devices were secured independently to the surrounding tissue.The distributor stated that the implanting clinician did not comply with the product instructions for use with respect to securing the stimulator before anchoring the receiver.The procedure for securing the stimulator instructs clinicians to ensure the stimulator is sutured to the tissue near the needle entry site (05-0669-2, page 24, k171366), and for fixating the receiver, physicians may need to cut down in order to find a suitable tissue structure for anchoring (05-0669-2, page 26, k171366).It is possible that clinician did not cut down deep enough to bury the receiver and spare lead in order to mitigate migration.It is equally likely that clinician's did not properly secure and fixate the devices to tissue, and the suture knot failed.Additionally, given the patient's noncompliance with follow-up appointments, it is possible that the patient did not comply with post-operative instructions to reduce activity to allow the devices to scar in.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 likely attributed to the implanting clinician's noncompliance to device indications for use detailed in the product's instruction for use for securing the device (ifu, 05-0669-2, pages 24 and 26, k171366): 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 noncompliance to post-operative instructions to reduce physical movements during the first few weeks.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 distributor from march 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 early movements.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 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 Description

The patient was implanted with stimq peripheral nerve stimulator (pns) system on (b)(6) 2018, in which one (1) stimq receiver stimulators (stq4-rcv-a0) and one (1) stimq spare lead (stq4-spr-b0) were implanted next to the supra-scapular nerves in her the left shoulder to treat patient's chronic shoulder and supra-scapular pain.There were no complications during the procedure.The patient was non-responding or communicating with the distributor or the implanting clinician after procedure.Both the distributor and the healthcare facility attempted to contact the patient for follow-up but were unable to establish communication.Thus, the patient missed several appointments with implanting clinician to establish follow up care.The implanting physician closed his practice on (b)(6) 2018, and the distributor became aware that patient care was transferred to another practice, but this practice also reported that the patient would miss appointments for follow-up.On (b)(6) 2019 the patient attended a follow-up appointment with the new clinician and the distributor.An x-ray determined devices migrated off the target nerves, one device was visualized in the patient's neck, the other device was observed under the patient's arm.The treating clinician discussed the options for device revision with the patient, but the patient elected for device explant.A procedure date has not been scheduled.

• Brand Name: STIMQ PERIPHERAL NERVE STIMULATOR (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: 8470993
• MDR Text Key: 140542988
• Report Number: 3010676138-2019-00018
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020464
• UDI-Public: (01)00818225020464(17)200801(01)00818225020495(17)200701(21)208530-18
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K1713966
• 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: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2020
• Device Model Number: STQ4-RCV-A0, STQ4-SPR-B0
• Device Lot Number: SWO180808, SWO180717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/04/2019
• Device Age: 1 MO
• Event Location: Home
• Date Manufacturer Received: 03/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2018
• 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