MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-08 for STIMQ PERIPHERAL NERVE STIMULATOR STQ4-SPR-B0 manufactured by Stimwave Technologies Inc..
[175068288]
Immediately following notification, stimwave quality and the territory manager reviewed events preceding the issue. Following a successful trial, the patient had a permanent procedure performed on (b)(6) 2019, in which one (1) stimq spare lead (stq4-spr-b0) was implanted at the lateral femoral cutaneous nerve on the patient's left leg. The territory manager was not present at the time of the implant procedure and was not able to confirm appropriate suturing and anchoring steps were followed according to the instructions for use. On (b)(6) 2019, the patient contacted the territory manager to report pain in their leg. The patient was instructed to contact the implanting clinician. The patient visited the implanting clinician the same day and reported the increased pain in their leg. The implanting clinician took imaging tests of the patient's implant and the x-rays showed the device had migrated medially towards the inside of the patient's leg. The implanting clinician made a new incision to remove the device. The explant procedure was completed without complications. The patient reported to be getting extensive pain relief prior to the time of the event. Since the patient has expressed interest in continuing to use the device, the implanting clinician is monitoring the patient's healing and will schedule an implant procedure when the patient is fully healed. Stimulator migration is a known adverse event for peripheral nerve stimulators that is mitigated as far as possible in the product's risk management file. The territory manager was not present at the time of the implant, so it is unknown at this time if the root cause is attributed to poor anchoring and suturing technique, or non-compliance to implanting instructions. The device did not fail to perform its essential functions. Up until the moment of the reported event, the patient was receiving therapy from their device. The root cause of the complaint is not attributed to device failure, the inability of the device to meet performance or safety specifications, or nonconformance to physical or functional device specifications. The stimwave product was not the source of the issue. The root cause is likely due to poor anchoring technique, however investigation efforts could not confirm it. 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, mitigated as far as possible, and documented in the stimwave risk management file. Stimwave was in constant contact with the territory manager from december 16, 2019, onward regarding the complaint and the root cause investigation. Stimwave confirmed that the implant procedure details steps to mitigate 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 resulted in a serious injury that required medical or surgical intervention to prevent or preclude permanent impairment or damage. This event was reported to the united states food and drug administration (fda) on january 8, 2020.
Patient Sequence No: 1, Text Type: N, H10
[175068289]
Stimwave quality has investigated the details regarding a complaint resulting from device migration reported to stimwave on december 16, 2019, by territory manager.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010676138-2020-00001 |
| MDR Report Key | 9564533 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-08 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2019-12-13 |
| Device Manufacturer Date | 2019-02-26 |
| Date Added to Maude | 2020-01-08 |
| 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 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 |
| Generic Name | PERIPHERAL NERVE STIMULATOR |
| Product Code | GZF |
| Date Received | 2020-01-08 |
| Model Number | STQ4-SPR-B0 |
| Lot Number | SWO190424 |
| 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 33064 US 33064 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-08 |