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

Model Number STQ4-SPR-B0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of consciousness (2418)

Event Date 10/26/2021

Event Type  Injury  

Manufacturer Narrative

The other adverse events issues questionnaire was reviewed for potential causes of the reported issue.Based on this review, using the waa when the incident occurred, implanting the device at an off-labeled location, implanting the stimulator too close to the nerve, and puncturing bone or tissue during the procedure have been ruled out as potential causes of the reported issue.The questionnaire shows it is unknown whether the patient had any contraindicating conditions which may have contributed to the occurrence.However, the clinical representative reported the patient has had issues with anesthesia in the past.The stimulator is used to treat pain.The cause of the unresponsiveness to anesthesia is due to the patient being a poor candidate due to health, weight, age, or mental capacity (user error - clinician).

Event Description

The patient was unresponsive in post op/recovery.An ambulance was called and the patient was taken to the hospital.The patient is well and has recovered and the device remains implanted.

• 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: 12863121
• MDR Text Key: 281192901
• Report Number: 3010676138-2021-00234
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020495
• UDI-Public: 010081822502049517230501
• 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: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2023
• Device Model Number: STQ4-SPR-B0
• Device Lot Number: SWO210516
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2021
• 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