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

Model Number STQ4-SPR-B0, STQ4-RCV-A0

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Skin Infection (4544)

Event Date 01/05/2021

Event Type  Injury  

Manufacturer Narrative

The patient-reported attending a follow-up appointment with a primary care physician, who advised the patient to follow-up with the implanting clinician because the wound seemed to be infected and one of the leads appeared to be eroding.The patient reached out to the clinical representative immediately.The clinical representative recommended the patient call the implanting clinician's office and schedule a follow-up.On (b)(6) 2020, the patient was seen by one of the associates of the implanting clinician, who determined that the tail of the lead was protruding out of the patient's incision and recommended the leads be removed and re-implanted.The patient was instructed to follow-up with the implanting clinician on (b)(6) 2020, to discuss further options.On (b)(6) 2020, the implanting clinician told the patient that the plan is to explant and implant new leads immediately after bwc grants the approval.On (b)(6) 2021, the clinical representative was made aware by the patient that during a follow-up appointment on (b)(6) 2020, that the infection was found to be getting worse, and the implanting clinician explanted both leads and prescribed antibiotics (dosage, name, frequency unknown) to treat the infection.The implanting clinician plans to implant new stimulators once the infection has cleared.The procedure was reported to have been performed per the product ifu.Stimwave has confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.The cause of the infection is no problem found.

Event Description

Complaint (b)(4) was received on (b)(6) 2020.The clinical representative was made aware that a recently implanted patient was suspect of potential infection and erosion at the wound site.

• 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: 11301498
• MDR Text Key: 230985472
• Report Number: 3010676138-2021-00004
• Device Sequence Number: 1
• Product Code: GZF
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/09/2021

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: 03/01/2022
• Device Model Number: STQ4-SPR-B0, STQ4-RCV-A0
• Device Lot Number: SWO200305, SWO200320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention