MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-01 for STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM STQ4 RCV-A0, STQ4-SPR-B0 manufactured by Stimwave Technologies Inc..
[140594791]
Stimwave quality has investigated the details surrounding a complaint resulting from a device migration that was reported to stimwave on (b)(6) 2019, by territory manager, (b)(6). On (b)(6) 2019 the patient attended an appointment with their implanting clinician and territory manager for device reprogramming because he was not experiencing pain relief with his device. An x-ray taken on this date showed the superior cluneal lead migrated caudal and posterior into his leg. The device at the medial cluneal nerve had not migrated, thus territory manager was able to establish stimulation with the implant located in the medial cluneal. The implanting clinician has scheduled the patient for revision on (b)(6) 2019. Immediately following notification, stimwave quality contacted the sales representative to discuss the events leading up to awareness of the issue. On (b)(6) 2019 following a successful trial with the stimq peripheral nerve stimulator (pns) system, the patient had one (1) stimq stimulator (stq4-rcv-a0) and one (1) stimq spare lead (stq4-spr-b0) implanted along the left superior cluneal nerve, and medial cluneal nerve to treat the patient's low back pain. There were no complications during the procedure, and the patient was discharged the same day reporting significant pain relief with his device. Immediately following notification, stimwave quality, reviewed the implanting clinician's procedure with the territory manager compared to the receiver instructions for use. The territory manager stated that the implanting clinician did not comply with the product instructions for use with respect to securing the stimulator and anchoring the receiver. The territory manager recalled that the implanting clinician performed only one of the two steps for migration mitigation. The procedure for securing the stimulator instructs clinicians to ensure the stimulator is sutured to the tissue (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). The territory manager did not observe the implanting clinician secure the stimulator; rather, he only fixated the receiver. 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 suture knot failed. 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 peripheral nerve stimulators and the stimq pns system and is mitigated as far as possible in the product's risk management file. Stimwave believes that if the implanting clinician would have followed the ifu, securing the stimulator and anchoring the receiver, this kind of adverse event is less likely to occur. Additionally, given the time between implant and issue onset (less than 4 weeks), it is possible that the patient did not comply with post-operative instructions to reduce activity to allow the devices to scar in. 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 migration mitigation steps as detailed in the product's instruction for use. 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 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)(6) 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. 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 april 1, 2019.
Patient Sequence No: 1, Text Type: N, H10
[140594792]
On (b)(6) 2019 the patient attended an appointment with their implanting clinician and territory manager for device reprogramming because he was not experiencing pain relief with his device. An x-ray taken on this date showed the superior cluneal lead migrated caudal and posterior into his leg. The device at the medial cluneal nerve had not migrated, thus territory manager was able to establish stimulation with the implant located in the medial cluneal. The implanting clinician has scheduled the patient for revision on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010676138-2019-00019 |
| MDR Report Key | 8471651 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-01 |
| Date of Report | 2019-04-01 |
| Date of Event | 2019-03-05 |
| Date Facility Aware | 2019-03-06 |
| Date Mfgr Received | 2019-03-06 |
| Device Manufacturer Date | 2018-07-01 |
| Date Added to Maude | 2019-04-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ELIZABETH GREENE |
| Manufacturer Street | 1310 PARK CENTRAL BOULEVARD S. |
| Manufacturer City | POMPANO BEACH FL 33064 |
| Manufacturer Country | US |
| Manufacturer Postal | 33064 |
| Manufacturer Phone | 8009655134 |
| Manufacturer G1 | STIMWAVE TECHNOLOGIES INC. |
| Manufacturer Street | 1310 PARK CENTRAL BOULEVARD S. |
| Manufacturer City | POMPANO BEACH FL 33064 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33064 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM |
| Generic Name | PERIPHERAL NERVE STIMULATOR |
| Product Code | GZF |
| Date Received | 2019-04-01 |
| Model Number | STQ4 RCV-A0, STQ4-SPR-B0 |
| Lot Number | SWO180717, SWO180808 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STIMWAVE TECHNOLOGIES INC. |
| Manufacturer Address | 1310 PARK CENTRAL BOULEVARD S. POMPANO BEACH FL 33064 US 33064 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-01 |