MAUDE Adverse Event Report: STIMWAVE TECHNOLGIES 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 Inflammation (1932)

Event Date 02/06/2018

Event Type  Injury  

Manufacturer Narrative

The patient was implanted on (b)(6) 2017 with a freedom receiver stimulator (fr8a-rcv-a0).There were no complications experienced during the procedure and the patient was sent home the same day following recovery at the implanting clinic.The patient was prescribed antibiotics (ciproflexin 500mg 3x/day) following implantation.Over the following three (3) months, the patient developed irritation near the receiver incision.The patient is very thin, and the location of the receiver incision was in close proximity to her waist band.The clinician cautioned the patient against itching the site or picking at the wound while it healed to limit potential of infection and encourage wound healing.On (b)(6) 2017, the patient followed up at the clinic for discomfort and irritation near the receiver incision and was prescribed a second course of antibiotics (ciproflexin 500 mg 3x/day).Sequential follow ups included additional antibiotic treatment and an mri, which confirmed that she did not have an infection.Throughout all the follow ups, the patient reported no issues with therapy, adequate coverage, and pain relief.As a precaution, the stimulator was explanted on (b)(6) 2018 to prevent any spread of potential infection.Upon explantation, there was no migration of the stimulators.The issues was reported to stimwave on (b)(6) 2018.On (b)(6) 2018, the patient was experiencing chills and visited another physician who prescribed antibiotics (ciproflexin 500 mg 3x/day).As of (b)(6) 2018, the patient reported no fever or adverse symptoms.Immediately following notification, stimwave management and quality reviewed the procedure and after care with the therapy consultant and the implanting clinician.Stimwave was informed that the patient does not have any pre-existing conditions.During this investigation, the clinical specialist confirmed that on the day of implantation, 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 with placement or programming.During the follow-up appointments, the clinician took infection prevention measures by proscribing additional courses of antibiotics.At the (b)(6) 2018 follow-up, the clinician determined that device explant would prevent any potential infection.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 patient constantly itching and picking the site of the wound, personal hygiene, or home environment.The device did not fail to meet performance or safety specification.Stimwave will continue to trend events.At this time, it is undetermined that the device caused or contributed to the event.The root cause of the complaint is not attributed to device failure or inability to meet performance or safety specifications.The root cause is likely attributed to patient itching and picking the site of the wound, 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 therapy consultant and the implanting clinician starting (b)(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 15, 2018.

Event Description

The patient was implanted on (b)(6) 2017 with a freedom receiver stimulator (fr8a-rcv-a0).There were no complications experienced during the procedure and the patient was sent home the same day following recovery at the implanting clinic.The patient was prescribed antibiotics (ciproflexin 500mg 3x/day) following implantation.Over the following three (3) months, the patient developed irritation near the receiver incision.The patient is very thin, and the location of the receiver incision was in close proximity to her waist band.The clinician cautioned the patient against itching the site or picking at the wound while it healed to limit potential of infection and encourage wound healing.On (b)(6) 2017, the patient followed up at the clinic for discomfort and irritation near the receiver incision and was prescribed a second course of antibiotics (ciproflexin 500 mg 3x/day).Sequential follow ups included additional antibiotic treatment and an mri, which confirmed that she did not have an infection.Throughout all the follow ups, the patient reported no issues with therapy, adequate coverage, and pain relief.As a precaution, the stimulator was explanted on (b)(6) 2018 to prevent any spread of potential infection.Upon explantation, there was no migration of the stimulators.The issues was reported to stimwave on (b)(6) 2018.On (b)(6) 2018, the patient was experiencing chills and visited another physician who prescribed antibiotics (ciproflexin 500 mg 3x/day).As of (b)(6) 2018, the patient reported no fever or adverse symptoms.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLGIES 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: 7277592
• MDR Text Key: 100398720
• Report Number: 3010676138-2018-00003
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00859619004875
• UDI-Public: (01)00859619004875(17)190801(01)00859619004929(17)190801(21)206639-12
• 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: 02/15/2018

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: No Information
• Device Expiration Date: 08/01/2019
• Device Model Number: FR8A-RCV-A0;FR8A-SPR-B0
• Device Catalogue Number: S8R-1A US
• Device Lot Number: 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
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 02/16/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention