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

Model Number PDBT-915-2K

Device Problem Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Date 12/10/2021

Event Type  malfunction  

Event Description

The patient reported their wearable antenna assembly gets hot after turned on causing a burning sensation to the skin.

Manufacturer Narrative

For the report of overheating: due to the short on the power amplifier (pa), the battery would never fully charge and may feel warm while charging.The waa is unable to provide therapy while charging; the patient would not be using the unit at this time.Thermal imaging was used to verify the outside temperature of the device while charging (front and back) and the internal temperature while charging.Results are as follows: front outside thermal temperature while charging: 31.9°c, back outside thermal temperature while charging: 31.8°c, internal thermal temperature while charging: 34.8°c.The outside thermal temperature while charging was 31.9°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.Although the reported issue of overheating could not be confirmed, the investigation found the power amplifier was blown - shorted. this caused high current draw (0.6amps) and prevented the battery from fully charging.In addition, it caused the battery to discharge quickly.Reference capa-0042 for additional battery investigation details.In addition to the blown power amplifier, the investigation found the unit board was damaged by liquid ingress the cause is attributed to pcb failure due to liquid damage.Attached to the investigation report is a picture that shows the presence of liquid on the board.

• Brand Name: PERIPHERAL NERVE STIMULATOR
• Type of Device: 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: 13218792
• MDR Text Key: 289986057
• Report Number: 3010676138-2022-00004
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020150
• UDI-Public: 0100818225020150
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PDBT-915-2K
• Device Lot Number: 00455-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1