MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-05 for STIMQ PERIPHERAL NERVE STIMULATOR STQ-SPR-B0; STQ4-RCV-A0 manufactured by Stimwave Technologies Inc..
[177946951]
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 (stq4-rcv-a0; sn: (b)(4)) was implanted at the left shoulder and one (1) stimq neurostimulator (stq4-spr-b0 sn: (b)(4)) was implanted in the right shoulder. On (b)(6) 2019, one (1) stimq neurostimulator (stq4-spr-b0 sn: (b)(4)) was explanted and one (1) stimq neurostimulator (stq4-spr-b0 sn: (b)(4)) was implanted as a revision to the right shoulder. The territory manager was present at the time of the implant procedure and confirmed appropriate suturing and anchoring steps were followed per the product instructions for use. On (b)(6) 2020, the patient contacted the territory manager to report a migration with skin irritation on the right shoulder. The receiver coil at the end of the device was protruding from the skin (erosion). On (b)(6) 2020, patient met with the implanting physician, who determined that surgical intervention (explant) was necessary. The implanting physician also prescribed antibiotics (keflex) as a preventative measure to reduce the potential for infection. At this time, the patient is reported to be recovering without any further complications. Upon further investigation it was discovered that complaint (b)(4) was previously assigned to a migration that occurred with this patient in (b)(6) 2019. The complaint concluded that a revision was scheduled. It was discovered that the revision complaint (b)(4) referenced was an explant of one device (sn: (b)(4)) and implant of a new device (sn: (b)(4)) being implanted immediately after, performed on (b)(6) 2019. The implanting physician determined a surgical intervention (revision) was necessary to re-establish therapy from migration, but the revision was not required to preclude permanent impairment of a body function or permanent damage to a body structure. It was noted that this clinician has only performed this operation on this one patient. Stimulator migration is a known adverse event for peripheral nerve stimulators that are reduced as far as possible in the product's risk management file. The territory manager was present at the time of the implant, so it is known at this time that the root cause is not 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. No issue was noted with the implant (sn: (b)(4)) on the left shoulder, and this device continues to deliver therapy. 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 root cause is likely due to activities being more strenuous on the right shoulder of the patient as it was confirmed the patient was right hand dominant. The implant on the left shoulder continues to deliver therapy with no reported issues. 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 contact with the territory manager from january 13, 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 the event required medical or surgical intervention to prevent or preclude permanent impairment or damage.
Patient Sequence No: 1, Text Type: N, H10
[177946952]
Stimwave quality has investigated the details regarding a complaint resulting from device migration reported to stimwave on january 13, 2020, by a territory manager.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010676138-2020-00007 |
| MDR Report Key | 9673203 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-01-13 |
| Date Mfgr Received | 2020-01-13 |
| Device Manufacturer Date | 2019-02-26 |
| Date Added to Maude | 2020-02-05 |
| 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 |
| Product Code | GZF |
| Date Received | 2020-02-05 |
| Model Number | STQ-SPR-B0; STQ4-RCV-A0 |
| Lot Number | SWO190424; SWO190423 |
| 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 | 2020-02-05 |