MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-05-15 for STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM FR8A-TRL-B0 manufactured by Stimwave Technologies Inc..
[145255953]
Stimwave quality has investigated the details surrounding a complaint resulting from infection reported to stimwave on (b)(4) 2019, by stimwave territory manager. On (b)(6) 2019, the territory manager was made aware by the patient that he had scratched through the layers of tegaderm concealing his trial stimq peripheral nerve stimulator (pns) system and in the process, had dislodged the device implanted in his left leg, nearly pulling it out completely. The territory manager immediately contacted the implanting clinician and he instructed the patient to completely remove the device from his left leg, cover the wound site with over-the-counter antibiotic ointment and a bandage and return to the clinic on (b)(6) 2019 for evaluation and removal of the other trial device. On (b)(6) 2019, the implanting clinician removed the trial device implanted in the patient's right leg and noted no issues with that wound site. Upon evaluation of the left leg, the implanting clinician observed that the skin was red and inflamed and the patient presented with a low-grade fever. The implanting clinician instructed the patient to seek treatment at an emergency room. The patient was treated with intravenous (iv) antibiotics (vancomycin) at a local hospital, and released the same day with a prescription of oral antibiotics (name, dose, and duration is unknown). On (b)(6) 2019, the patient reported that the wounds sites were healed and was fully recovered. Because the patient received significant relief of his pain during the trial, he is planning to have a permanent device implanted. Stimwave does not know the date of the permanent procedure. 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 patient was implanted with the trial stimq pns system in which one trial device (fr8a-trl-a0 and fr8a-trl-b0) was placed in each leg along the peroneal nerve to treat the patient's chronic foot pain. 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 territory manager informed the patient on the day of the trial that he should refrain from touching the bandages and ensure that the area remains clean to help prevent infection. On (b)(6) 2019, the patient reported that while he was sleeping, the bandages over his left leg were irritating and he was scratching to wound site in response. The patient tore the bandaging from his skin and in the process, inadvertently grasped the trial (fr8a-trl-b0) device, leading to partial removal. The patient did not report any irritation in the other leg during the trial. It is not known how long the patient experienced the irritation, or if he voluntarily removed the bandages against doctor orders. The territory manager informed stimwave that the patient was a heavy smoker who did not stop smoking during the trial. The territory manager reported that the infection was only observed in the left leg, and the patient was continuing to use the trial stimq pns system to treat the pain in his right leg. The implanting clinician did not observe any alleged deficiency in the product with respect to product identity, quality, durability, reliability, safety, effectiveness, or performance. On (b)(6) 2019, the patient reported that he had made a full recovery following antibiotic treatment (iv and oral). 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 personal hygiene, home environment and noncompliance to infection prevention following a surgical procedure. The device did not fail to meet performance or safety specifications. At this time, it is unlikely that the device caused or contributed to the issue. However, it is likely attributed to patient constantly itching the wound, personal hygiene, or home environment. The patient's personal hygiene and home environment are uncontrolled factors that may have contributed to the presentation of the infection. However, it is likely attributed to a lack of compliance to wound care practices at the patient's home environment. The device did not fail to meet performance or safety specifications during the trial. Stimwave will continue to trend events. Stimq contraindications (instructions for use, 05-00669-2, page 5) include: poor surgical risks - peripheral nerve stimulators should not be used on patients who are poor surgical risks, patients with multiple illnesses, or active general and/or skin infections. This includes patients who need anticoagulation therapy that cannot be temporarily halted to accommodate the implantation procedure. 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 no further infection in his left leg, reported no other issues or adverse events, and is interested in a permanent device. The implanting clinician has recommended that the patient quit smoking cigarettes before the permanent procedure to aid with infection prevention. 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 patient's personal hygiene, home environment and noncompliance to infection prevention following a surgical procedure. 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 may 6, 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 15, 2019.
Patient Sequence No: 1, Text Type: N, H10
[145255955]
On (b)(6) 2019, the territory manager was made aware by the patient that he had scratched through the layers of tegaderm concealing his trial stimq peripheral nerve stimulator (pns) system and in the process, had dislodged the device implanted in his left leg, nearly pulling it out completely. The territory manager immediately contacted the implanting clinician and he instructed the patient to completely remove the device from his left leg, cover the wound site with over-the-counter antibiotic ointment and a bandage and return to the clinic on (b)(6) 2019 for evaluation and removal of the other trial device. On (b)(6) 2019, the implanting clinician removed the trial device implanted in the patient's right leg and noted no issues with that wound site. Upon evaluation of the left leg, the implanting clinician observed that the skin was red and inflamed and the patient presented with a low-grade fever. The implanting clinician instructed the patient to seek treatment at an emergency room. The patient was treated with intravenous (iv) antibiotics (vancomycin) at a local hospital, and released the same day with a prescription of oral antibiotics (name, dose, and duration is unknown). On (b)(6) 2019, the patient reported that the wounds sites were healed and was fully recovered. Because the patient received significant relief of his pain during the trial, he is planning to have a permanent device implanted. Stimwave does not know the date of the permanent procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010676138-2019-00022 |
| MDR Report Key | 8614047 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-05-15 |
| Date of Report | 2019-05-15 |
| Date of Event | 2019-05-05 |
| Date Facility Aware | 2019-05-05 |
| Date Mfgr Received | 2019-05-05 |
| Device Manufacturer Date | 2019-02-01 |
| Date Added to Maude | 2019-05-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 2019-05-15 |
| Model Number | FR8A-TRL-B0 |
| Lot Number | SWO190222 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 3 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 | 2019-05-15 |