MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. STIMQ NEUROSTIMULATOR; WEARABLE ANTENNA ASSEMBLY

Model Number	PDBT-915-2K
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	08/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2021, stimwave received a complaint in which the patient had reported to the clinical representative experiencing a shock sensation while wearing the waa.Stimwave initiated (b)(4) to return the device for investigation.The device history record was reviewed, and no non-conformances or issues which could have led to the failure of the device were identified.On (b)(6) 2021, stimwave investigated the device for the alleged shock.The device was verified on an engineering bench and tested in the factory waa test.Investigation determined that the problem is related to incorrect waa settings programmed by the stimwave clinical representative.
Event or Problem Description
The patient reported unintended stimulation while wearing the wearable antenna assembly.

• Brand Name: STIMQ NEUROSTIMULATOR
• Common Device Name: WEARABLE ANTENNA ASSEMBLY
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• MDR Report Key: 12493397
• Report Number: 3010676138-2021-00200
• Device Sequence Number: 3920863
• Product Code: GZF
• UDI-Device Identifier: 00818225020150
• UDI-Public: 0100818225020150
• 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: 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): 09/17/2021

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 Model Number: PDBT-915-2K
• Device Lot Number: 00461-DT
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 09/18/2021
• 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