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

Model Number FR8A-RCV-A0

Device Problem Expulsion (2933)

Patient Problem Skin Erosion (2075)

Event Date 09/16/2019

Event Type  Injury  

Manufacturer Narrative

Stimwave quality has investigated the details regarding a complaint resulting from a skin irritation and device erosion reported to stimwave on september 17, 2019.The clinical specialist was made aware on september 16, 2019, by the implanting clinician.Immediately following notification, stimwave quality and the clinical specialist reviewed events preceding the issue.The patient had a permanent procedure performed on (b)(6) 2018, were one (1) freedom-8a receiver stimulator (fr8a-rcv-a0) was implanted at the t8-t9 vertebrae.The clinical specialist 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 clinical specialist maintained contact with the patient following implant.On (b)(6) 2019, the patient contacted the clinical specialist to report that the device was protruding through the skin.The patient visited the implanting clinician for evaluation the same day.The clinical specialist observed that the excess tubing from the stimulator was protruding through the skin, however the proximal end of the device remained implanted.The implanting clinician decided to revise the device prophylactically.The section of the device that was protruding was removed.The device remains implanted and no other complications were reported.The patient is getting therapy from the device.The clinical specialist reported that during the patient's post-implant course, the patient would constantly pick at the wound, which disturbed the wound's healing process.The patient was instructed to not touch the implant wound and let the implant site heal properly.When the wound was evaluated by the implanting clinician and the clinical specialist, the device appeared to have been pulled out of the implant site.The root cause of the issue was attributed to patient non-compliance.Device erosion is known adverse event for spinal cord stimulators and the freedom-8a (scs) system (receiver instructions for use, 05-00629-6, page 14) and is mitigated as far as possible in the product's risk management file.The source of the issue cannot be traced back to the device.The device did not fail to meet performance or safety specifications.Stimwave will continue to track and trend events.The root cause of the issue is attributed to patient non-compliance to post-implant instructions.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 patient non-compliance.Corrective action is not required to remedy the root cause of the complaint.The device did not fail to meet performance or safety specifications.Device erosion is a known adverse event for spinal cord stimulation and the freedom scs system that is mitigated as far as possible and documented in the stimwave risk management file.Stimwave's global device erosion rate is <0.1%.Stimwave was in constant contact with the clinical specialist from september 17, 2019, onward regarding the complaint and the root cause investigation.The root cause of the issue is attributed to patient non-compliance stimwave confirmed that the product did not fail to meet performance and safety specifications.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 this event required medical intervention by a health care professional to prevent or preclude potential permanent impairment or damage.Stimwave reported this issue to the united states food and drug administration (fda) on october 15, 2019.

Event Description

Stimwave quality has investigated the details regarding a complaint resulting from a skin irritation and device erosion reported to stimwave on (b)(6) 2019.The clinical specialist was made aware on (b)(6) 2019, by the implanting clinician.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR (SCS)
• 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: 9193156
• MDR Text Key: 162662049
• Report Number: 3010676138-2019-00031
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00859619004875
• UDI-Public: (01)00859619004875(17)190801
• 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: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 08/01/2019
• Device Model Number: FR8A-RCV-A0
• Device Catalogue Number: S8R-1A US
• Device Lot Number: SWO170810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2019
• Initial Date FDA Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2017
• 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