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

Model Number	FR8A-TRL-A0
Health Effect - Clinical Codes	Erosion (1750); Skin Inflammation/ Irritation (4545)
Date of Event	02/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient had a permanent procedure performed on (b)(6) 2019, in which one freedom-8a receiver stimulator (fr8a-rcv-a0) was implanted.The clinical representative cannot confirm that the implant procedure was completed according to the product instructions for use since the clinical representative was not present at the time of the implant.The patient reported receiving therapy.The implanting clinician plans to perform a revision to correct the erosion, and the procedure has not been scheduled.The implanting clinician prescribed antibiotics to prevent infection (dosage, name, and frequency unknown).Based on this information, the device erosion was confirmed/replicated.There is no evidence that the product did not meet specifications, and the stimulator is used to treat pain.The cause of the erosion is unknown/no problem found.
Event or Problem Description
Stimulator had perforated the skin on the lower leg.

• 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: 11429647
• Report Number: 3010676138-2021-00032
• Device Sequence Number: 3776482
• Product Code: GZF
• UDI-Device Identifier: 00818225020679
• UDI-Public: 010081822502067917200301
• 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: 2019
• 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): 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/01/2021
• Device Model Number: FR8A-TRL-A0
• Device Lot Number: SWO180322
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1