MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-18 for STIMQ NEUROSTIMULATOR STQ4-RCV-A0; STQ4-SPR-B0 manufactured by Stimwave Technologies Inc..
[184147440]
Immediately following the notification, stimwave quality and the cr reviewed events preceding this is event. Following a successful trial, the patient had two (2) stimq peripheral nerve stimulators were implanted at the bilateral superior cluneal nerve: p/n: stq4-rcv-a0, s/n: (b)(4), lot #: swo191025, exp. Date: october 01, 2021. P/n: stq4-spr-b0, s/n: (b)(4), lot #: swo190423, exp. Date: october 01, 2021. The cr confirmed that the implant procedure was performed in a sterile environment, sterile field handling protocols were used, and the sterile barriers of all product used were intact prior to implant. The procedure was completed without complication. As per questionnaire dated, february 24, 2020, the cr reported that on (b)(6) 2020, the patient admitted being intoxicated and fell face-forward to the ground (accident). The patient was scheduled for the follow-up visit on (b)(6) 2020, where the patient had mentioned that he had the accident. Since proper tonic was not received, x-rays were ordered by the physician. X-rays were taken on (b)(6) 2020, where the physician determined that the leads had migrated - and advised that a revision would need to be performed in order to correct the leads. On (b)(6) 2020 - the physician performed the revision, explanting both stimulators successfully. Once the explant was completed, two (2) new stimq peripheral nerve stimulators were implanted at the bilateral superior cluneal nerve with no complications observed. The patient then continued with therapy and content. The physician stated that the devices were damaged, causing migration due to the patient's accident. Stimulator migration is a known adverse event for spinal nerve stimulators that are reduced as far as possible in the product's risk management file. The device did not fail to perform its essential functions. Through a review of sterilization and packaging records for the respective lots, stimwave has confirmed that the product was delivered sterile, no trend of infection is evident for lot #'s swo191025 and swo190423, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging. The root cause of this event could not be attributed to the inability of the devices to meet physical, functional, performance and/or safety specifications. Since the revision/explanting was performed, the patient has been receiving therapy from the device and is very content. The root cause of this event is attributed to the accident the patient had on (b)(6) 2020 - that caused the leads to migrate. 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, reduced as far as possible, and documented in the stimwave risk management file. Stimwave was in contact with the cr from (b)(6) 2020, onward regarding the complaint and the root cause investigation. Stimwave confirmed that the implant procedure details steps to reduce migration, and that the product did not fail to meet performance and safety specifications. Stimwave has informed all parties that the product was not the source 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 the event required medical or surgical intervention to prevent or preclude permanent impairment or damage
Patient Sequence No: 1, Text Type: N, H10
[184147441]
Stimwave quality has investigated the details regarding a potential migration after a fall reported to stimwave on (b)(6) 2020, by clinical representative
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010676138-2020-00026 |
| MDR Report Key | 9848224 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-18 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-08-29 |
| Date Added to Maude | 2020-03-18 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS MARY ANN GREENAWALT |
| Manufacturer Street | 1310 PARK CENTRAL BOULEVARD S. |
| Manufacturer City | POMPANO BEACH, |
| Manufacturer Country | US |
| Manufacturer G1 | STIMWAVE TECHNOLOGIES INC. |
| Manufacturer Street | 1310 PARK CENTRAL BOULEVARD S. |
| Manufacturer City | POMPANO BEACH, |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STIMQ NEUROSTIMULATOR |
| Generic Name | PERIPHERAL NERVE STIMULATOR |
| Product Code | GZF |
| Date Received | 2020-03-18 |
| Model Number | STQ4-RCV-A0; STQ4-SPR-B0 |
| Lot Number | SWO191025; SWO190423 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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, US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-18 |