MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. STIMQ NEUROSTIMULATOR; PERIPHERAL NERVE STIMULATOR

Model Number	FR8A-TRL-A0
Health Effect - Clinical Codes	Stroke/CVA (1770); Numbness (2415)
Date of Event	06/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The implanting clinician referred the patient to the emergency room to receive care and get an mri.On (b)(6) 2020 the stimulator was explanted at the hospital since the patient needed to get the mri done.The patient was diagnosed with a mild stroke at the hospital and was released on (b)(6) 2020.On an unknown date the implanting clinician and the emergency room physician confirmed to the clinical representative that the mild stroke suffered by the patient was not related to the stimulator implantation.The clinical rep stated that the implant was used off label.A review of the certificate of conformance shows that the product was manufactured in accordance to specifications.The stimulator was reported to meet product specifications.Device can not currently be received by manufacturer for analysis.The device was used for treatment of pain.The device cannot be traced as the source of the issue.The cause of the issue is unknown/no problem found.
Event or Problem Description
On (b)(6) 2020, the patient called the implanting clinician stating that the patient's whole right arm and hand was numb, was confused and had drool coming out of right side of his mouth.

• Brand Name: STIMQ NEUROSTIMULATOR
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• MDR Report Key: 11399955
• Report Number: 3010676138-2021-00022
• Device Sequence Number: 4532270
• Product Code: GZF
• UDI-Device Identifier: 00818225020679
• UDI-Public: 010081822502067917220301
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/01/2022
• Device Model Number: FR8A-TRL-A0
• Device Lot Number: SWO200305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR