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

Model Number STQ4-RCV-A0

Device Problem Material Erosion (1214)

Patient Problems Post Operative Wound Infection (2446); Skin Inflammation/ Irritation (4545)

Event Date 12/29/2020

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2021, the clinical representative became aware that a recently implanted patient was experiencing an infection at the wound site after a revision was performed to correct an erosion.The implanting clinician confirmed an infection was present and treated the patient with antibiotics (name, dosage, frequency unknown).The clinical representative confirmed the patient completed the antibiotic treatment and the infection is clear.However, the patient is completing about a new pain in her leg and wants to have the stimulator explanted.The implanting clinician has explained to the patient that the new pain is not related to the stimulator.However, the patient is adamant about an explant.The clinical representative 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 products used were intact before the implant.A stimwave representative reviewed sterilization and packaging records for the respective product lot and was able to confirm that the product was delivered sterile, sterilized using validated sterilization parameters, and sterile barriers were verified to be intact following packaging.Based on this information, the infection was confirmed/replicated.There is no evidence that the product did not meet specifications, and the stimulator is used to treat pain.The cause of the infection is unknown/no problem found.

Event Description

On (b)(6) 2021, the clinical representative became aware that a recently implanted patient was experiencing an infection at the wound site after a revision was performed to correct an erosion.

• Brand Name: STIMQ NEUROSTIMULATOR
• Type of Device: PERIPHERAL NERVE 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: andrea najera ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 11389563
• MDR Text Key: 233946745
• Report Number: 3010676138-2021-00019
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020464
• UDI-Public: 010081822502046417220901
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2021

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: Lay User/Patient
• Device Expiration Date: 09/01/2022
• Device Model Number: STQ4-RCV-A0
• Device Lot Number: SWO200929
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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