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

Model Number STQ4-RCV-A0

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Erosion (1750)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2021, the implanting clinician had a follow-up appointment with the patient and successfully performed an explant procedure.The patient has reported no further issues.The implanting clinician prescribed antibiotics after the explant procedure (dosage, frequency, name unknown).The clinical representative followed up with the implanting clinician to inquire about what may have caused the erosion.However, the implanting clinician stated that he is unsure of the cause.The clinical representative also noted that the patient had followed post-op instructions and had not engaged in any physical activity requiring excessive bending, stretching, or twisting.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.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 device erosion is a known issue with mitigation controls in place to reduce risk as far as possible and no corrective action is required.Per previous investigations conducted for the same reported issue, the following are potential causes of the event: patient not following post-op instructions.Patient engaging in excessive physical activity.Not following ifu during the implant procedure.

Event Description

Stimulator lead was coming out of skin and required an explant.

• 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: 11758585
• MDR Text Key: 248400472
• Report Number: 3010676138-2021-00083
• 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: 05/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2021
• 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: SWO200604
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2021
• 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