MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. STIMQ PERIPHERAL NERVE STIMULATOR

Model Number	FR4A-TRL-A0;FR4A-TRL-B0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	10/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Immediately following notification, stimwave quality and the territory manager reviewed events preceding the issue.The patient had a permanent procedure performed on (b)(6) 2019, in which one (1) stimq receiver stimulator (stq4-rcv-a0) and one (1) spare lead (stq4-spr-b0).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 reported drainage at the wound site to the implanting clinician.The patient visited the implanting clinician the same day for follow up.At the visit the implanting clinician took cultures of the wound site.The results returned positive for methicillin-resistant staphylococcus aureus (mrsa).The implanting clinician made the decision to explant the devices.The territory manager was notified on november 13, 2019 when contacted by the implanting clinician.The patient reported to be receiving therapy up until the moment of the explant.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 peripheral nerve stimulators that 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 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 device failure, the inability of the device to meet performance or safety specifications, or nonconformance to physical or functional device specifications.The stimwave product was not the source of the issue.The root cause of the issue is likely attributed to unknown patient comorbidities or 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.Stimwave has confirmed that the issue is a known adverse event, mitigated as far as possible, and documented in the stimwave risk management file.Stimwave was in constant contact with the territory manager from november 13, 2019, onward regarding the complaint and the root cause investigation.Stimwave confirmed that the product did not fail to meet performance and safety specifications.Stimwave has informed all parties that the product was not the source 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 the event resulted in a serious injury that required medical intervention to prevent impairment or permanent damage.This event was reported to the united states food and drug administration (fda) on december 6, 2019.
Event or Problem Description
Stimwave quality has investigated the details regarding a complaint resulting from an infection reported to stimwave on (b)(6) 2019, by territory manager.

• Brand Name: STIMQ PERIPHERAL NERVE STIMULATOR
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• MDR Report Key: 9418645
• Report Number: 3010676138-2019-00061
• Device Sequence Number: 2579068
• Product Code: GZF
• UDI-Device Identifier: 00818225020594
• UDI-Public: (01)00818225020594(17)210301(01)00818225020587(17)210301(21)201248-23
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• 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): 12/05/2019

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: 03/01/2021
• Device Model Number: FR4A-TRL-A0;FR4A-TRL-B0
• Device Lot Number: SWO190321; SWO190321
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/05/2019
• 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