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

Model Number STQ4-RCV-A0

Device Problem Material Erosion (1214)

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

Event Date 03/09/2021

Event Type  Injury  

Manufacturer Narrative

The implanting clinician explained to the clinical representative the leads were not visible.However, a very small portion of something blue was visible, which the implanting clinician believes is the suture eroding, not the stimulator.The clinical representative confirmed that the implant procedures were completed in accordance with the product instructions for use.The patient reported receiving therapy.The implanting clinician inspected the site and decided not to revise the suture.Based on this information, the device erosion was not confirmed/replicated, there is no evidence that product did not meet specification and the stimulator is used for treatment of pain.The cause of the suture erosion is unknown/no problem found; the device did not erode.Design fmea 06-0537 and hra 06-0524 was reviewed and device erosion is a known issue with mitigation controls in place to reduce risk as far as possible therefore, no capa is required.Stimwave's global device erosion rate: 0.32% and the impact is important and the frequency is occasionally.

Event Description

On (b)(6) the clinical representative was contacted by the implanting clinician to disclose that a recently implanted patient with one stim-q stimulator at the left knee had an erosion at the surgical pocket 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: 11634876
• MDR Text Key: 245094529
• Report Number: 3010676138-2021-00063
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020464
• UDI-Public: 010081822502046417220601
• 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: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• 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
• Device Lot Number: SWO200608
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2021
• 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