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

Model Number STQ4-RCV-A0

Device Problem Material Erosion (1214)

Patient Problems Skin Erosion (2075); Skin Inflammation/ Irritation (4545)

Event Date 02/11/2021

Event Type  Injury  

Manufacturer Narrative

The clinical representative instructed the patient to contact the implanting clinician's office to schedule a follow-up appointment.On (b)(6) 2021, the patient attended a follow-up appointment with the implanting clinician.During this visit, the implanting clinician determined the patient's leads had eroded, and the leads needed to be explanted.The implanting clinician decided to perform an explant procedure on (b)(6) 2021.The patient and the implanting clinician decided to re-implant the stimulator at a later time.The implanting clinician mentioned to the clinical representative that one of the contributing factors for the erosion taking place is the patient's poor skin quality.The clinical representative confirmed that the implant procedure was performed in a sterile environment with sterile field handling protocols, sterile barriers of all products used were intact before the implant, and the procedure was completed in accordance with the product instructions for use.A stimwave representative conducted a review of sterilization and packaging records for the respective product lot; stimwave has confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.Based on this information, the erosion 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 erosion is unknown/no problem found.Design fmea for stimq 06-01233 and hra for stimq 06-01232 was reviewed and erosion is a known issue with mitigation controls in place to reduce risk as far as possible and no corrective action is required.

Event Description

On (b)(6) 2021, the patient contacted the clinical representative to report that the leads had eroded through the skin.

• Brand Name: STIMQ NEUROSTIMULATOR
• Type of Device: PERIPHERAL NEWRVE 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: 11478673
• MDR Text Key: 239662012
• Report Number: 3010676138-2021-00043
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020464
• UDI-Public: 010081822502046417221001
• 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: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2022
• Device Model Number: STQ4-RCV-A0
• Device Lot Number: SWO201025
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2021
• 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