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

Model Number	FR8A-RCV-A0, FR8A-RCV-B0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Type of Reportable Event	Death
Additional Manufacturer Narrative
Immediately following notification, stimwave quality reviewed events preceding the issue.The patient had a trial procedure performed on (b)(6) 2016, 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 october 25, 2019, stimwave was notified the patient had passed away (exact date unknown).Information received attributed the death to a drug overdose.The event 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.There is no indication the device could have caused or contributed to the patient's death.The device was not implanted at the time of the event.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 21, 2019.
Event or Problem Description
Stimwave quality has investigated the details regarding a complaint resulting from a patient death, unrelated to the device, reported to stimwave on october 25, 2019.

• 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
• MDR Report Key: 9355122
• Report Number: 3010676138-2019-00051
• Device Sequence Number: 11363406
• Product Code: GZB
• UDI-Device Identifier: 00859619004875
• UDI-Public: (01)00859619004875(17)180701(01)00859619004882(17)180701(21)STF1000605-17
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/01/2018
• Device Model Number: FR8A-RCV-A0, FR8A-RCV-B0
• Device Catalogue Number: S8R-1A US
• Device Lot Number: SWL160705A, SWL160705B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death