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 Problem Pain (1994)

Event Date 03/02/2022

Event Type  Injury  

Manufacturer Narrative

The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, the script was completed with limited information.Follow-up correspondence with the clinical representative ruled out the following potential causes: inadequate fixation, implanting the device in an off-label location, patient participating in strenuous physical activity too soon post-op and incorrect device positioning.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.The stimulator is used to treat pain.The cause of the loss of therapy is the erosion and the cause of the erosion is unknown.Therefore, conclusion has been selected as no problem/fault found.

Event Description

The patient reported their stimulator was not taking their pain away like it did during the trial.The patient experienced pain that was migrating towards the front of their right shoulder.Additionally, the patient reported one of their leads eroded however it is unknown which stimulator was explanted.The patient is doing fine other than slight soreness where the lead was explanted.

• 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: alicia pagliaro ; 1310 park central boulevard s.; pompano beach, FL 33064
• MDR Report Key: 14052561
• MDR Text Key: 288882775
• Report Number: 3010676138-2022-00043
• 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: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2020
• Device Model Number: STQ4-RCV-A0, STQ4-SPR-B0
• Device Lot Number: SWO180815, SWO201119
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2022
• 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