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 Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

The patient was implanted on (b)(6) 2017 with a freedom receiver stimulator (fr8a-rcv-a0) and spare lead (fr8a-spr-b0).There were no complication experienced during the procedure and the patient was sent home the same day following recovery at the implanting clinic.The patient was prescribed antibiotics (keflex) for seven (7) days following implantation.The patient followed up at the clinic on (b)(6) 2017 and (b)(6) 2018 and reported no issues with therapy and adequate coverage and pain relief.Additionally, the clinician did not identify any issues with the wound during each of those follow up visits.At the next follow-up on (b)(6) 2018, the clinician observed that the electrode incision sites appeared to be healing, but the receiver incision site was inflamed and reddened.An additional course of antibiotics (keflex) was prescribed for an additional seven (7) days.At the next follow up on (b)(6) 2018, the clinician visually identified a skin infection at the receiver incision site, which was not healing.The stimulators were explanted on (b)(6) 2018 to prevent any potential spread of the infection.The patient was prescribed different oral antibiotics (augmentin and amoxicillin) for an additional 14 days.Stimwave was notified of the issue on february 6, 2018.The patient was reviewed for incision wound healing on (b)(6) 2018 and reported no new issues following explantation.The clinician confirmed that the wound was healing.Immediately following notification, stimwave management and quality reviewed the procedure and after care with the clinical specialist and the implanting clinician.The clinician was unable to provide the clinic's infection prevention protocol, but was able to confirm that the implanting clinician completed two other procedures on the same day, and there were no other infections reported subsequently from those procedures.Additionally, the clinician informed stimwave that the patient's pre-existing conditions made her more susceptible to infections ((b)(6) and diabetic).Thus, the infection is isolated to this single patient.During this investigation, the clinical specialist confirmed that on the day of the implant, the product packaging was not damaged, and the sterile barrier remained intact prior to the implant.The implant was completed in accordance with the product instructions for use.The stimulator was successfully programmed and the patient reported pain relief and good stimulation on implant day.There were no reported complications or issues.Because of the patient's pre-existing conditions, the clinician had the patient follow up at various intervals post-implantation to check the incision sites for healing.It was during this follow-up appointment that the clinician took infection prevention measures by proscribed an additional course of oral antibiotics.At the (b)(6) 2018 follow up, it was clear that the infection was not responding to oral antibiotics, and the clinician determined that device explant would assist in preventing any future spread of infection.Following device explant, the clinician prescribed two different oral antibiotics for 14 days.The patient followed up on (b)(6) 2018 and the patient reported improvement and the clinician noted that the wound was healing.The patient is reported to be in good health.Stimwave reviewed sterilization records on product from inventory to rule out any issues with product sterility.Record review confirmed the products from the same/similar lots are sterile out of the package.The source of the issue was not traced back to compromised product sterility or operating room conditions.At this time, it is undetermined that the device caused or contributed to the issue.However it is likely attributed to the patient's susceptibility to infection due to pre-existing conditions, personal hygiene or home environment.The device did not fail to meet performance or safety specification, and the patient continues to use the device for treatment.Stimwave will continue to trend events.The root cause of the complaint is not attributed to device failure or the inability of the device to meet performance or safety specifications.The root cause is likely attributed to the patient's susceptibility to infection due to pre-existing conditions, personal hygiene or home environment.It is not confirmed if the patient complied with antibiotics treatment prescribed as a part of after-procedure care.There is not enough information about the patient's home environment or personal hygiene or care to confirm the source of the issue.The stimwave product was not the source of the issue.Corrective action is not required to remedy the root cause of the complaint.The device did not fail to meet performance or safety specification.Stimwave has confirmed that the product was delivered sterile, and the sterile barriers were not compromised.Stimwave was in constant contact with the clinical specialist and the implanting clinician starting february 6, 2018 regarding the complaint and the root cause investigation.Stimwave confirmed that the product was provided sterile and did not fail to meet performance and safety specifications, and verified that the surgery center had demonstrated compliance with sterilizations standard for implantation procedures for treatment.Stimwave has informed all parties that the stimwave product was not the source of the issue.In compliance with medical device reporting requirements and responsibilities, stimwave has reported this complaint as an adverse event to the fda on february 14, 2018.

Event Description

The patient was implanted on (b)(6) 2017 with a freedom receiver stimulator (fr8a-rcv-a0) and spare lead (fr8a-spr-b0).There were no complication experienced during the procedure and the patient was sent home the same day following recovery at the implanting clinic.The patient was prescribed antibiotics (keflex) for seven (7) days following implantation.The patient followed up at the clinic on (b)(6) 2017 and (b)(6) 2018 and reported no issues with therapy and adequate coverage and pain relief.Additionally, the clinician did not identify any issues with the wound during each of those follow up visits.At the next follow-up on (b)(6) 2018, the clinician observed that the electrode incision sites appeared to be healing, but the receiver incision site was inflamed and reddened.An additional course of antibiotics (keflex) was prescribed for an additional seven (7) days.At the next follow up on (b)(6) 2018, the clinician visually identified a skin infection at the receiver incision site, which was not healing.The stimulators were explanted on (b)(6) 2018 to prevent any potential spread of the infection.The patient was prescribed different oral antibiotics (augmentin and amoxicillin) for an additional 14 days.Stimwave was notified of the issue on february 6, 2018.The patient was reviewed for incision wound healing on (b)(6) 2018 and reported no new issues following explantation.The clinician confirmed that the wound was healing.

• 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: 7277682
• MDR Text Key: 100305705
• Report Number: 3010676138-2018-00002
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dental Assistant
• Type of Report: Initial
• Report Date: 02/14/2018

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: Health Professional
• Device Expiration Date: 08/01/2019
• Device Model Number: FR8A-RCV-A0;FR8A-SPR-B0
• Device Lot Number: SWO171023;SWO170822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 6 MO
• Event Location: Outpatient Treatment Facility
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 02/16/2018
• 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): Congenital Anomaly; Required Intervention