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

Model Number	FR8A-SPR-B0, STQ4-RCV-A0
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting an expired simulator was ruled out as a potential cause.Other potential causes of the reported issue are off-label use, migration, infection, patient contraindications, implanting a non-sterile device, using inappropriate tools, erosion and surgical issue.The stimulator is used to treat pain.The cause of the new pain is unknown.Therefore, conclusion has been selected as no problem/fault found.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in new pain.New pain rates remain consistent and acceptably low; thus, capa is not required.New pain rates will continue to be tracked and trended.
Event or Problem Description
The patient reported pain at the receiver pocket when they press on it and they can see the wire under the skin.The patient has not been wearing the wearable antenna assembly.Additionally, they have not been able to get an x-ray to confirm stimulator location as they are dealing with other unrelated health issues.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR
• Common Device Name: SPINAL CORD 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: 14986611
• Report Number: 3010676138-2022-00088
• Device Sequence Number: 19251081
• Product Code: GZB
• UDI-Device Identifier: 00818225020648
• UDI-Public: (01)00818225020648(17)210701(01)00818225020464(17)211001(21)211054-115
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2022

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 Expiration Date: 07/01/2021
• Device Model Number: FR8A-SPR-B0, STQ4-RCV-A0
• Device Lot Number: SWO190701, SWO191024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2019
• 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