MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-04 for STIMQ PERIPHERAL NERVE STIMULATOR STQ4-RCV-A0; STQ4-SPR-B0 manufactured by Stimwave Technologies Inc..
[188232954]
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 neurostimulator (pn stq4-rcv-a0, sn (b)(4)) was implanted at the left side of the superior cluneal nerve and one (1) stimq neurostimulator (pn stq4-spr-b0, sn (b)(4)) was implanted at the right side of the superior cluneal nerve. The territory manager was not present at the time of the implant procedure to confirm appropriate suturing and anchoring steps were followed per the instructions for use. On (b)(6) 2020, the patient met with the implanting clinician concerning a loss of therapy. The implanting clinician determined that migration was the cause and elected to perform a revision or explant on (b)(6) 2020, to re-establish therapy and prevent potential outward migration (erosion). The stimulator on the right side had migrated outward, and the stimulator on the left side had migrated minimally, but still caused a loss of therapy. The patient reported no falls or impact that could have contributed to stimulator migration. On (b)(6) 2020, the physician notified the territory manager that the revision was rescheduled due to inclement weather. The patient has several diagnostic tests pending for prior conditions unrelated to the stimulators. The clinician will make determination to either explant or revise in the best interest of the patient's health following provision of test results. On march 4, 2020, clinical representative stated that the operation date is scheduled for (b)(6) 2020. The patient has not reported any new issues at this time. This issue was originally assessed for reportability on january 23, 2020 and determined to be reportable. On february 5, 2020, the issue was re-assessed incorrectly as not reportable as the migration had not caused injury (erosion). On march 4, 2020, issue was re-evaluated as reportable, as surgical intervention will be performed to prevent potential injury from erosion. Capa (b)(4) has been initiated to address mdr reporting timeliness and evaluations. 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 root cause cannot be attributed with certainty to poor anchoring and suturing technique or non-compliance to implanting instructions. No information was provided by patient, physician, or clinical representative stating that the device did not fail to perform its essential functions. Up until the moment of the reported event, the patient was receiving therapy from the devices. The root cause cannot be confirmed with certainty at this time, as the implanting clinician has not been able to see the patient for a follow up since january 8, 2020. 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. Capa (b)(4) has been initiated to address mdr reporting timeliness and evaluations. Stimwave was in contact with the territory manager from january 14, 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 surgical intervention will be performed to prevent or preclude potential impairment or damage.
Patient Sequence No: 1, Text Type: N, H10
[188232955]
Stimwave quality has investigated the details regarding a complaint resulting from device migration reported to stimwave on (b)(6) 2020, by territory manager.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010676138-2020-00020 |
| MDR Report Key | 9788800 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-04 |
| Date of Report | 2020-01-08 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-01-08 |
| Device Manufacturer Date | 2018-07-26 |
| Date Added to Maude | 2020-03-04 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 9655134 |
| 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 PERIPHERAL NERVE STIMULATOR |
| Generic Name | PERIPHERAL NERVE STIMULATOR |
| Product Code | GZF |
| Date Received | 2020-03-04 |
| Model Number | STQ4-RCV-A0; STQ4-SPR-B0 |
| Lot Number | SWO180815; SWO190202 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-04 |