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

Model Number FR8A-RCV-A0

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Erosion (2075)

Event Date 01/29/2019

Event Type  Injury  

Manufacturer Narrative

Stimwave quality has investigated the details surrounding a complaint resulting from device erosion through the skin reported to stimwave on (b)(6) 2019, by (b)(6) clinical specialist.On (b)(6) 2019, the clinical specialist was made aware that a patient's stimulator had eroded through his skin while attended an appointment with the patient and the implanting clinician.During this appointment, the patient reported that he had noticed the device placed above his eye protruding through his skin slightly, but the wound was slightly reddened but not inflamed, or bleeding.The patient recounted that he contacted the implanting clinician regarding the issue.The clinical specialist was not aware of this communications between the implanting clinician and the patient until (b)(6) 2019.The implanting clinician evaluated the device erosion and did not observe any signs of infection.He also verified that the other two devices had neither migrated nor presented any evidence of device erosion.The implanting clinician recommended that the device be revised.On (b)(6) 2019, the implanting clinician revised the stimulator without complication.To prevent device erosion in the future, the clinician did not advance the device as far medial, as the area over the patient's right eye was not as muscular, and the skin was thin.The patient did not report any issues and is continuing to use freedom scs system and receives significant pain relief.Immediately following notification, stimwave quality and management contacted the clinical specialist to discuss the events leading up to awareness of the issue.The patient was implanted with the freedom spinal cord stimulator (scs) system on (b)(6) 2019, in which two (2) freedom-8a receiver stimulators (fr8a-rcv-a0) and one (1) freedom-8a spare lead (fr8a-spr-b0) were implanted off-label in above and below his right eye and in the right side of his mandible to treat the patient's trigeminal neuralgia.There were no complications during the procedure.The patient experienced pain relief after the procedure and on (b)(6) 2019, the patient continued to report excellent pain relief with the system.The clinical specialist reported that the implanting clinician was aware of the freedom scs system indications for use and the off-label nature of the procedure performed on (b)(6) 2019.Because the procedure was off-label, stimwave could not review the implantation procedure against the indications for use.The clinical specialist reported that facility where the implant performed is a teaching hospital, and the implanting clinician had the resident suture the device implanted above the patient's right eye.All other devices were sutured by the implanting clinician, and did not have any issue.It is possible that the resident's suture technique was not sufficient, or that the resident may have inadvertently advanced the device medially during suture application.The clinical specialist reported that the patient repeated touched the device erosion site at the (b)(6) 2019 appointment, and it possible that the patient may have also contributed to the issue if he was rubbing or touching the implant through his skin.There was no infection noted during the revision procedure on (b)(6) 2019.Because the procedure was off-label, there was no implantation procedure available to review against the implanting clinician's technique.The potential contributing factors to this issue include: patient's physiology (thinner skin and less muscle around the eye), patient compulsion (touching and rubbing the implant under the skin), and procedure technique (resident secured the device that eroded).Based on these factors, and that the patient continues to use the freedom scs system for treatment of his trigeminal neuralgia, the source of the issue was not traced back to the device as it did not fail to meet performance or safety specifications.Stimwave will continue to trend events.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 is likely attributed to patient physiology, patient compulsion, and/or suturing procedure during implantation.The stimwave product was not the source of the issue.The patient is continuing to use the freedom scs system and is reporting good pain relief with the device.Corrective action is not required to remedy the root cause of the complaint.The device did not fail to meet performance or safety specifications.Stimwave has confirmed that the issue is a known risk, mitigated as far as possible, and documented in the stimwave's risk management file.Stimwave was in constant contact with the clinical specialist starting january 29, 2019, regarding the complaint and the root cause investigation.Stimwave confirmed that while the implant procedure was off-label, the product did not fail to meet performance and safety specifications.Stimwave has informed all parties that the product was 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 erosion of the device through the skin can lead to an injury, and medical or surgical intervention was required to preclude permanent impairment or damage.Stimwave has reported this as an adverse event to the united states food and drug administration (fda) on february 11, 2019.

Event Description

On (b)(6) 2019, the clinical specialist was made aware that a patient's stimulator had eroded through his skin while attended an appointment with the patient and the implanting clinician.During this appointment, the patient reported that he had noticed the device placed above his eye protruding through his skin slightly, but the wound was slightly reddened but not inflamed, or bleeding.The patient recounted that he contacted the implanting clinician regarding the issue.The clinical specialist was not aware of this communications between the implanting clinician and the patient until (b)(6) 2019.The implanting clinician evaluated the device erosion and did not observe any signs of infection.He also verified that the other two devices had neither migrated nor presented any evidence of device erosion.The implanting clinician recommended that the device be revised.On (b)(6) 2019, the implanting clinician revised the stimulator without complication.To prevent device erosion in the future, the clinician did not advance the device as far medial, as the area over the patient's right eye was not as muscular, and the skin was thin.The patient did not report any issues and is continuing to use freedom scs system and receives significant pain relief.

• 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: 8329718
• MDR Text Key: 135871069
• Report Number: 3010676138-2019-00005
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020792
• UDI-Public: (01)00818225020792(17)200201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180981
• 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: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2020
• Device Model Number: FR8A-RCV-A0
• Device Lot Number: SWO180206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/29/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Manufacturer Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• 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