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

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

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Skin Inflammation/ Irritation (4545)

Event Date 03/15/2021

Event Type  Injury  

Manufacturer Narrative

The clinical representative stated that the implanting clinician had not provided a treatment plan, and no further information was available.The clinical representative noted that the implanting clinician was unsure of what might have caused the erosion.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 device erosion was confirmed/replicated.There is no evidence that the product did not meet specifications.The cause of the erosion is unknown/no problem found.Design fmea for stimq (b)(4) and hra for stimq (b)(4) 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 clinical representative was contacted by the implanting clinician to disclose a recently implanted patient was experiencing erosion at the coil 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: 11668789
• MDR Text Key: 245502985
• Report Number: 3010676138-2021-00068
• 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: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2022
• Device Model Number: STQ4-RCV-A0, STQ4-SPR-B0
• Device Lot Number: SWO200605, SWO190614
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2021
• 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): Other