MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. PERIPHERAL NERVE STIMULATOR; WEARABLE ANTENNA ASSEMBLY

Model Number	PDBT-915-2K
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	02/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient stated that the device overheats and measured the external temperature to be 102° f (39.9° c).Iec 60101-1, sub-clause 11.1.2 - temperature of applied parts, limits the temperature of medical devices in contact with a patient's skin to 43°c for adults, and 41°c for minors and other high risk groups.The patient did not return the waa for analysis; however, based on the patient's report, the temperature of the waa is below the maximum allowed by the standard.The waa instructions for use prohibit waa placement directly on the skin.The waa design has been verified to not exceed the maximum specification established per the standard, as documented in test report number (b)(4)verification testing.Further, risk of overheating is reduced by a protection mechanism implemented in the waa, causing it to shut down if it reaches an internal temperature of 70 degrees c.The temperatures measured on waas without insulation during verification testing are consistent with what the patient reported.In the absence of the unit for analysis, it is concluded that the temperature observed by the patient is consistent with the waa temperature during operation and is below the maximum temperature permitted by the safety standard.
Event or Problem Description
The patient stated their wearable antenna assembly is hot to the touch after use and measured the external temperature to be 102° f using an infrared laser thermometer.
Additional Manufacturer Narrative
Investigation of the device was unable to replicate the alleged issue, and no nonconformances were found.For the report of overheating: thermal imaging was used to verify the outside temperature of the device while operating, outside temperature while charging, and the internal temperature while operating.Results are as follows: outside thermal temperature while operating: 26.4°c outside thermal temperature while charging: 25.7°c internal thermal temperature while operating: 35.8°c the outside thermal temperature while charging was 25.7°c, which is below the product requirements specification of 41°c (106°f).Based on the thermal imaging, there is no evidence of thermal damage and the product met temperature specifications.
Event or Problem Description
The patient stated their wearable antenna assembly is hot to the touch after use and measured the external temperature to be 102° f using an infrared laser thermometer.

• Brand Name: PERIPHERAL NERVE STIMULATOR
• Common Device Name: WEARABLE ANTENNA ASSEMBLY
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer Contact: alicia pagliaro ; 1310 park central boulevard s.; pompano beach, FL 33064
• MDR Report Key: 13655811
• Report Number: 3010676138-2022-00027
• Device Sequence Number: 17461765
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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: 00536-DT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown