MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM NEUROSTIMULATOR; SPINAL CORD NERVE STIMULATOR

Model Number	PDBT-915-2K
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the peeling is visible, the reported issue of overheating and the cause of the peeling could not be replicated.For the report of peeling: visual inspection of unit shows unusual pattern of external corrosion, including paint peeling off.The corrosion like effect also propagated into the inside of the enclosure.Per the instructions for use for the wearable antenna assembly, the approved cleaning method is the following: clean with a damp cloth, mild household cleaners will not damage the device or labels.This has been validated by stimwave per (b)(4) -cleaning and durability of markings.Based on this test report and instructions for use, the waa has been tested to withstand mild household cleaners (such as isopropyl alcohol, bleach , soap, etc).This is the first reported complaint for peeling since commercial distribution.For the report of overheating: the pcb is in good condition, with the exception of the broken rf connector solder joint.There is no evidence of overheating on the pcb.The outside thermal temperature while charging was 29.0°c, which is below the product requirements specification of 41°c (106°f).The pa failed open which does not cause excessive current draw.The device cannot overheat because there is no current draw.The likely cause of pa failure is the broken rf connector.There is evidence of intrusion of foreign matter into the enclosure, an unidentified particulate in the vicinity of the usb connector and the rf connector.The unidentified particulate did not cause the reported issue.Although the reported issue could not be replicated, the investigation found the rf connector was damaged.Based on this information, the complaint will be closed as no problem found for the reported issues of peeling and overheating.
Event or Problem Description
The patient reported their wearable antenna assembly gets hot and the outside is peeling.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Common Device Name: SPINAL CORD NERVE STIMULATOR
• 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: 12963610
• Report Number: 3010676138-2021-00238
• Device Sequence Number: 19930799
• Product Code: GZB
• 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
• Report Date (Section B): 12/07/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: PDBT-915-2K
• Device Lot Number: 00365-D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 12/08/2021
• 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