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

Model Number FR8-RCV-A0, FR8A-TRL-B0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Immediately following notification, stimwave quality reviewed events preceding the issue.The patient had a trial procedure performed on (b)(6) 2017, in which one (1) freedom-8a receiver stimulator (fr8a-rcv-a0) and one (1) spare lead (fr8a-spr-b0) were implanted bilaterally at the t8-t9 vertebral level.The procedure was completed without complications.On (b)(6) 2019, stimwave was notified the patient had passed away.The details regarding the cause of death were not disclosed to stimwave.However, information reported indicated the cause of death was not related to the device.At the time of the patient's death, the device was no longer in use and had already been explanted.The root cause of the complaint is not attributed to device failure, the inability of the device to meet performance or safety specifications, or nonconformance to physical or functional device specifications.The stimwave product was not the source of the issue.The device was no longer in use at the time of the patient's death.The event was related to unknown patient comorbidities.Corrective action is not required to remedy the root cause of the complaint.The device did not fail to meet performance or safety specifications.The patient's death was not related to the device.Stimwave confirmed that the product did not fail to meet performance and safety specifications.The source of was related to unknown patient comorbidites.Stimwave has informed all parties that the product was not the source issue.In compliance with medical device reporting requirements and responsibilities, stimwave quality and its chief medical officer have determined that this issue is considered reportable, as the event resulted in a death.This event has been reported to the united states food and drug administration (fda) on november 19, 2019.

Event Description

Stimwave quality has investigated the details regarding a complaint resulting from a patient death, unrelated to the device, reported to stimwave on (b)(6) 2019.

• Brand Name: FREEDOM SPINAL CORD STIMUATOR
• Type of Device: SPINAL CORD STIMUATOR
• 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: elizabeth greene ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 9341613
• MDR Text Key: 166984748
• Report Number: 3010676138-2019-00050
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00859619004875
• UDI-Public: (01)00859619004875(17)190101(01)00859619004912(17)181201(21)3233-3
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2018
• Device Model Number: FR8-RCV-A0, FR8A-TRL-B0
• Device Catalogue Number: S8R-1A US
• Device Lot Number: SWO170102; SWO1611207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2016
• 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
• Patient Outcome(s): Death