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 Skin Erosion (2075); Skin Infection (4544)

Event Date 03/11/2021

Event Type  Injury  

Manufacturer Narrative

The implant clinician prescribed antibiotics (name, frequency, dosage unknown) to control the infection and cleaned the area with antibiotic solution.The implanting clinician mentioned to the clinical representative that the patient has multiple conditions that may have contributed to the infection since the patient has type 2 diabetes and a hernia, which may have contributed to the erosion and the infection by pushing the leads the surface of the skin.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 infection/erosion was confirmed/replicated.There is no evidence that the product did not meet specifications, and the stimulator is used for the treatment of pain.The cause of the infection/erosion is due to preexisting patient conditions and the stimulator being placed at an off-label location.Design fmea for stimq 06-01233 and hra for stimq 06-01232 was reviewed and infection/erosion are known issue with mitigation controls in place to reduce risk as far as possible and no corrective action is required.Stimwave's global device erosion rate: (b)(4).Stimwave's global infection rate: (b)(4).The frequency is occasionally and the impact is important.

Event Description

The stimulator was implanted on the intercostal area.On (b)(6) 2021, the patient went to a follow-up appointment with the implanting clinician who noticed the stimulator was eroding and successfully performed an explant procedure on the same date.

• 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: 11646564
• MDR Text Key: 245988008
• Report Number: 3010676138-2021-00066
• 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: Other
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2021
• Device Model Number: STQ4-SPR-B0, STQ4-RCV-A0
• Device Lot Number: SWO190614, SWO191025
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2021
• 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