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

Model Number	FR4A-TRL-B0
Health Effect - Clinical Code	Erosion (1750)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The implanting clinician explained to the clinical representative that the patient claimed the area was itchy and inadvertently pulled the tail end of the lead.The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting a non-sterile device, not using antibiotics, and using inappropriate tools have been ruled out as potential causes.However, the patient interfered with the wound site.Stimulator is used for the treatment of pain.The cause of the erosion is user error due to patient non-compliance to the ifu.
Event or Problem Description
On (b)(6) 2021, the implanting clinician performed an explant procedure to remove the stimulator.

• 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: 11867354
• Report Number: 3010676138-2021-00096
• Device Sequence Number: 11678306
• Product Code: GZF
• UDI-Device Identifier: 00818225020587
• UDI-Public: 010081822502058717220301
• 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: 2021
• 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): 05/21/2021

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: FR4A-TRL-B0
• Device Lot Number: SWO200329
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/21/2021
• 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