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

Model Number	FR8A-RCV-A0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Stimwave quality has investigated the details regarding a complaint resulting from incision site not healing and suspected infection reported to stimwave on september 23, 2019, by territory manager.Immediately following notification, stimwave quality and the territory manager reviewed the events preceding issue.The patient had a permanent procedure performed on (b)(6) 2019, in which one (1) freedom-8a receiver stimulator (fr8a-rcv-a0), and one (1) spare lead (fr8a-spr-b0) were implanted at the t8-t9 vertebral level for lower back pain.The territory manager 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 territory manager maintained contact with the patient following implant.On (b)(6) 2019, the patient visited the implanting clinician and reported redness and irritation at the incision site.The implanting clinician evaluated the wound and observed the proximal end of the receiver was attempting to protrude at the pocket side, as well as redness and irritation.The implant clinician made the decision to explant the device prophylactically due to a suspected infection.The implanting clinician did not take cultures of the wound site, so the infection was not confirmed.The patient was sent home the same day with antibiotics for ten (10) days (dosage unknown).The territory manager reported that the patient had a previous infection were the patient's spare lead was explanted.During the explant procedure, the implanting clinician made the incision at the incorrect location.It is likely that during this procedure the patient's wound got contaminated and contributed to the patient's ongoing infection.Through a review of sterilization and packaging records for the respective product lots, stimwave has confirmed that the product was delivered sterile, no trend of infection is evident for either lot, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.Infection is a known adverse event for spinal cord stimulators (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 device sterility or procedure.The device did not fail to meet performance or safety specifications.Stimwave will continue to track and trend events.The root cause of the complaint is not attributed to implant procedure, 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 is attributed to patient history of infection that could have contributed to the wound site not healing.Corrective action is not required to remedy the root cause of the complaint.The device did not fail to meet performance or safety specifications.Infection is a known adverse event for spinal cord stimulators and the freedom scs system that is mitigated as far as possible and documented in the stimwave risk management file.Stimwave's global infection rate is <0.5%.Stimwave was in constant contact with the territory manager from september 23, 2019, onward regarding the complaint and the root cause investigation.Through a review of sterilization records and adverse event trending for the stimulator lots, stimwave confirmed that the product did not fail to meet performance or 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 21, 2019.
Event or Problem Description
Stimwave quality has investigated the details regarding a complaint resulting from an incision site not healing and suspected infection reported to stimwave on september 23, 2019, by territory manager.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• MDR Report Key: 9213510
• Report Number: 3010676138-2019-00035
• Device Sequence Number: 343755
• Product Code: GZB
• UDI-Device Identifier: 00859619004875
• UDI-Public: (01)00859619004875(17)191101
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K182720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/21/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/01/2019
• Device Model Number: FR8A-RCV-A0
• Device Catalogue Number: S8R-1A US
• Device Lot Number: SWO171109
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention