MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM

Model Number FR8A-RCV-A0; FR8A-SPR-B0

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

Patient Problem Weakness (2145)

Event Date 10/02/2019

Event Type  Injury  

Manufacturer Narrative

Stimwave quality has investigated the details regarding a complaint resulting from weakness following procedure reported to stimwave on october 3, 2019.Immediately following notification, stimwave quality and the field trainer reviewed events preceding the issue.Following a successful trial, the patient had a permanent procedure performed on (b)(6) 2019, in which one (1) freedom-8a receiver stimulator (fr8a-rcv-a0), and one (1) spare lead (fr8a-spr-b0) were implanted at the t9 vertebral level to treat the patient for leg pain.The field trainer confirmed that the implant procedure was performed in a sterile environment, sterile field handling protocols were used, the procedure was completed in accordance with the product instructions for use, and the sterile barriers of all product used were intact prior to implant.The procedure was completed without complication, and the patient went home following the procedure.On (b)(6) 2019, after the patient went home, the patient contacted the implanting clinician to report they were unable to walk.The patient was admitted to the hospital and evaluated by the implanting clinician.The patient started physical therapy immediately after.It was confirmed the patient did not have nerve damage.The patient has a history of spasticity which possibly contributed to the weakness following the procedure.The implanting clinician does not believe that the root cause is related to the device.The patient is a traumatic brain injury patient and has had difficulty walking in the past.The reported weakness following the procedure was possibly related to the patient's past history of spasticity.The patient's medical history could have been a contributing factor of the reported issue.As of (b)(6) 2019, the patient is doing well.Physical therapy is ongoing, the patient is able to stand and walk for short periods of time.The patient reported to be receiving pain relief from their device.Following the implant procedure there was no report of a device problem, the stimulator was working as expected.The field trainer and the implanting clinician confirmed that the implanting procedure was completed according to the instructions for use.The root cause of the issue cannot be traced to a device failure or the inability of the device to meet performance.The root cause of the issue is possibly attributed to the patient's past medical history of spasticity.The root cause of the complaint is not attributed to device failure, the inability of the device to meet performance or safety specifications, nor nonconformance to physical or functional device specifications.The root cause of the issue is attributed to 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.Nerve damage is known adverse event for spinal cord stimulation and for the freedom spinal cord stimulator system documented in the product's risk management file and mitigated as far as possible.Stimwave will track and trend this complaint.Stimwave was in constant contact with the field trainer from (b)(6) 2019, onward regarding the complaint and the root cause investigation.The root cause of the issue is attributed to the patients past medical history of spasticity.Stimwave product is not the source of the 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 required medical or surgical intervention to preclude permanent impairment or damage.Stimwave has reported this as an adverse event to the united states food and drug administration (fda) on october 31, 2019.

Event Description

Stimwave quality has investigated the details regarding a complaint resulting from weakness following procedure reported to stimwave on october 3, 2019.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
• Type of Device: 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: elizabeth greene ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 9260565
• MDR Text Key: 168641036
• Report Number: 3010676138-2019-00039
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020693
• UDI-Public: (01)00818225020693(17)210901(01)00818225020648(17)210601(21)201278-22
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182720
• 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: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/01/2021
• Device Model Number: FR8A-RCV-A0; FR8A-SPR-B0
• Device Lot Number: SWO190904; SWO190614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/06/2018
• 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): Required Intervention