MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-05-14 for STIMQ PERIPHERAL NERVE STIMUATOR (PNS) SYSTEM STQ4-RCV-A0 manufactured by Stimwave Technologies Inc..
[145244058]
Stimwave quality has investigated the details surrounding a complaint resulting from an infection reported to stimwave on (b)(6) 2019, by stimwave territory manager. On (b)(6) 2019, the territory manager was made aware that the patient was being treated by the implanting clinician for an infection at and around the needle entry site of her implant. The patient reported to the territory manager that she was prescribed antibiotics (name, dose, duration is unknown) by the implanting clinician on (b)(6) 2019, and had an appointment on (b)(6) 2019 for device evaluation and potential explant. On (b)(6) 2019, the patient reported that the wound site was showing signs of healing. On (b)(6) 2019, the implanting clinician recommended device explant to ensure complete healing. It is not known if the patient will have a new device placed. As of (b)(6) 2019, the patient reported that the wound site was no longer inflamed, and was healing from the explant. Immediately following notification, stimwave quality contacted the territory manager to discuss the events leading up to awareness of the issue and to review the implanting clinician's infection prevention protocol. The territory manager reported that the patient was implanted with the stimq peripheral nerve stimulator (pns) system on (b)(6) 2019 in which a stimq stimulator (stq4-rcv-a0) was implanted at the patient's right posterior tibial nerve and a stimq spare lead (stq4-spr-b0) was implanted at the patient's left posterior tibial nerve to treat the patient's chronic pain in her feet. 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. There were no complications experienced during the procedure and patient was sent home the same day. The clinician implanted the stimulator and reported no complications or issues with placement or programming. The patient experienced pain relief after the procedure. The territory manager reported that he had met with the patient on (b)(6) 2019 for reprogramming, and did not observe any issues with the surgical site. During the reprogramming session, the territory manager was not aware of any alleged deficiency in the product with respect to product identity, quality, durability, reliability, safety, effectiveness, or performance. The territory manager reported that the infection was only observed in the right leg, at or around the suture site, and the patient was continuing to use the stimq pns system to treat the pain. While the wound site was cultured, the results of this test are unknown to stimwave. Because the infection was only present in one leg, and not both, the implanting clinician suspected that the patient might have inadvertently caused or contributed to the issue, by scratching or otherwise irritating the needle entry site. To rule out any potential issues with product sterility, stimwave reviewed sterilization records on product from inventory, which confirmed stimulators from the same lot are sterile out of the package. The territory manager also confirmed that on the day of the implant the product packaging was not damaged, and the sterile barrier remained intact prior to the implant. The raw data from sterilization cycle matched the cycle specification. Stimwave quality, engineering, and manufacturing verified that the correct cycle specification was used for the stimulator lot. The source of the issue was not traced back to compromised product sterility or operating room conditions. Stimwave reviewed the lot history distribution, and no trends of infections were noted. Surgical site infection is a known complication of surgery. The source of the issue is likely attributed to the patient's susceptibility to infection due to pre-existing conditions, surgical history, and potential noncompliance to infection prevention following a surgical procedure. The device did not fail to meet performance or safety specifications. At this time, it is undetermined that the device caused or contributed to the issue. However, it is likely attributed to patient constantly itching and picking the site of the wound, personal hygiene, or home environment. The device did not fail to meet performance or safety specification. Stimwave will continue to track and trend events. The source of the issue was not traced back to compromised product sterility or operating room conditions. As of (b)(6) 2019, the patient reported significant relief of her pain in her left leg, reported no other issues or adverse events, and is interested in a new device to replace the one explanted prophylactically. The root cause of the complaint is not attributed to device failure or inability to meet performance or safety specifications. The root cause is likely attributed to patient itching and picking the site of the wound, personal hygiene, or home environment. It is not confirmed if the patient complied with antibiotics treatment prescribed as a part of after-procedure care. There is not enough information about the patient's home environment or personal hygiene or care to confirm the source of the issue. 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 product was delivered sterile, and the sterile barriers were not compromised. Infection is a known adverse event that is detailed in stimwave's risk management file. Stimwave's product labeling includes statements for contraindications associated with active infections. Stimwave was in constant contact with the territory manager starting (b)(4) 2019 regarding the complaint and the root cause investigation. The device did not fail to meet performance or safety specifications. Stimwave has confirmed that the product was delivered sterile, and the sterile barriers were not compromised. The issue is a known risk and is mitigated as far as possible. 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 infection can lead to an injury, and medical or surgical intervention was 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 may 14, 2019.
Patient Sequence No: 1, Text Type: N, H10
[145244059]
On (b)(6) 2019, the territory manager was made aware that the patient was being treated by the implanting clinician for an infection at and around the needle entry site of her implant. The patient reported to the territory manager that she was prescribed antibiotics (name, dose, duration is unknown) by the implanting clinician on (b)(6) 2019, and had an appointment on (b)(6) 2019 for device evaluation and potential explant. On (b)(6) 2019, the patient reported that the wound site was showing signs of healing. On (b)(6) 2019, the implanting clinician recommended device explant to ensure complete healing. It is not known if the patient will have a new device placed. As of (b)(6) 2019, the patient reported that the wound site was no longer inflamed, and was healing from the explant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010676138-2019-00021 |
| MDR Report Key | 8609509 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-05-14 |
| Date of Report | 2019-05-14 |
| Date of Event | 2019-04-29 |
| Date Facility Aware | 2019-04-29 |
| Date Mfgr Received | 2019-04-29 |
| Device Manufacturer Date | 2018-08-01 |
| Date Added to Maude | 2019-05-14 |
| 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 STIMUATOR (PNS) SYSTEM |
| Generic Name | PERIPHERAL NERVE STIMULATOR |
| Product Code | GZF |
| Date Received | 2019-05-14 |
| Model Number | STQ4-RCV-A0 |
| Lot Number | SWO180808 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 9 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 | 2019-05-14 |