MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-28 for STIMQ NEUROSTIMULATOR STQ4-RCV-A0 manufactured by Stimwave Technologies Inc..
[187627707]
Immediately following notification, stimwave quality and the territory manager reviewed events preceding the issue. The patient had a permanent implant procedure performed on (b)(6) 2019, in which one (1) stimq peripheral nerve stimulator (p/n stq4-rcv-a0, s/n (b)(4)) was implanted at the right common peroneal nerve in the right leg below the knee. The territory manager confirmed that the implant procedure was performed in a sterile environment, sterile field handling protocols were used, the procedure was completed in accordance with the product instructions for use, and the sterile barriers of all product used were intact prior to implant. The procedure was completed without complication. The territory manager reported that the physician explanted the stimulator on (b)(6) 2020, due to an infection caused by an in-grown hair. Per the following evidence, stimwave quality has determined the root cause of the infection is not attributed to device: the issue occurred approximately seven months following the implant procedure. No complications were reported prior to february, 3, 2020, when the stimwave representative was made aware. At a routine follow-up with the patient and implanting clinician on (b)(6) 2020, the physician reported seeing no signs of infection. On february 3, 2020, the physician informed the territory manager that an in-grown hair caused the infection. The patient reported having early onset dementia, but this has not been confirmed to be a contributing factor to the event. Through a review of sterilization and packaging records for the respective product lots, stimwave has confirmed that the product was delivered sterile, no trend of infection is evident for lot swo180808, validated sterilization parameters were used, and sterile barriers were verified to be intact. No additional complications have been reported following explant. The root cause of the complaint could not be attributed to inability of the device to meet physical, functional, performance, or safety specifications. The root cause of this event is attributed to patient condition (in-grown hair infection) identified by the physician. Corrective action is not required to remedy the root cause of the complaint, as the device did not fail to meet performance or safety specifications and no trend of infection is evident for the sterilization lot. Stimwave has confirmed that the issue is a known adverse event, reduced as far as possible, and documented in stimwave's risk management files. Stimwave was in contact with the territory manager from february 3, 2020, onward regarding the complaint and the root cause investigation. Stimwave confirmed 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 intervention to preclude potential further injury.
Patient Sequence No: 1, Text Type: N, H10
[187627708]
Stimwave quality has investigated the details regarding a complaint of an infection reported to stimwave on february 3, 2020, by territory manager
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010676138-2020-00016 |
| MDR Report Key | 9769441 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2019-07-19 |
| Date Added to Maude | 2020-02-28 |
| 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, FL |
| 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 | 2020-02-28 |
| Model Number | STQ4-RCV-A0 |
| Lot Number | SWO180808 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STIMWAVE TECHNOLOGIES INC. |
| Manufacturer Address | 1310 PARK CENTRAL BOULEVARD S. POMPANO BEACH, FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-28 |