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

Model Number FR8A-TRL-A0

Device Problem Material Puncture/Hole (1504)

Patient Problem Headache (1880)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

Stimwave quality has investigated the details regarding a complaint resulting from device damaged during implant procedure reported to stimwave on (b)(6) 2019.Immediately following notification, stimwave quality and the territory manager reviewed events preceding the issue.The patient had a trial procedure scheduled to be performed on (b)(6) 2019, in which one (1) freedom receiver stimulator (fr8a-trl-a0) was to be implanted at the t8 vertebral level.The territory manager confirmed that the implant procedure was performed in a sterile environment, sterile field handling protocols were used, and the sterile barriers of all product used were intact prior to implant.During the implant procedure, when the implanting clinician attempted to insert the stylet, the implanting clinician reportedly felt resistance and could not advance the stylet further.The implanting clinician attempted to force the stylet through but was unable to continue.The implanting clinician and the territory manager used another stylet in order to continue with the procedure.The implanting clinician reported feeling resistance once again.When the implanting clinician inserted the device applying additional force, the patient reported feeling pain at the epidural region.The implanting clinician decided to remove the device and implant another device.The implanting clinician and the territory manager evaluated the explanted device and noticed the stylet had punctured the receiver.The device was exchanged, and the procedure was completed without further complications.On (b)(6) 2019, the patient contacted the territory manager with complaints of headaches.The patient was advised to contact their implanting clinician if the headaches persisted.As of (b)(6) 2019, the patient is doing well, and receiving therapy from their device.No further complications were reported.The device was returned and evaluated by stimwave.Visual inspection of the device demonstrated the stylet had gone through the receiver.The stimulator was visually inspected under a microscope.The device showed that the stylet had been pushed through the receiver's polyurethane membrane and had punctured the device.This issue was likely caused by the implanting clinician applying excessive force when introducing the stylet through the stimulator.The root cause was attributed to user error by the implanting clinician.This is the first reported issue of a punctured receiver.Manufacturing and lot records were reviewed, and the device was built to specification and verified functional through in-process and final inspections.This is the first reported issue of stimulator damage during procedure.Stimwave will monitor and trend this type of 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 root cause of the issue was attributed to user error by the implanting clinician.Corrective action is not required to remedy the root cause of the complaint.This type of issue will be monitored and trended.Stimwave was in constant contact with the territory manager from october 1, 2019, onward regarding the complaint and root cause investigation.The root cause of the issue is attributed to user error.In compliance with medical device reporting requirements and responsibilities, stimwave quality and its chief medical officer have determined that this event is considered reportable as the issue could have led to a serious injury or death.Stimwave reported this event to the united states food and drug administration on october 30, 2019.

Event Description

Stimwave quality has investigated the details regarding a complaint resulting from device damaged during implant procedure reported to stimwave on (b)(6) 2019.

• Brand Name: SPINAL CORD STIMULATOR
• Type of Device: FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
• 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: 9257977
• MDR Text Key: 219774128
• Report Number: 3010676138-2019-00038
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020679
• UDI-Public: (01)00818225020679(17)210701
• 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: 10/30/2019

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2021
• Device Model Number: FR8A-TRL-A0
• Device Lot Number: SWO190719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2019
• 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