MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM NEUROSTIMULATOR; SPINCAL CORD NERVE STIMULATOR

Model Number	FR8A-TRL-A0
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2021, the patient had one permanent stimulator implanted.The stimwave clinical representative (cr) was present during the implant procedure and confirmed the procedure was performed per the product instructions for use.The cr opened an scs 8 contact trial lead kit and observed the implanting clinician numbing the lumbar area before the tuohy needle entry.The patient was in a prone position.The clinician noticed the patient's oxygen saturation dropping and asked the nurse if the patient was ok.The implanting clinician directed the nurse to get the patient supine, after which the patient's vitals began to stabilize.Ems was called as a precaution.The cr was still at the clinic an hour later and was informed that the patient had passed away at the hospital.The implanting clinician explained to the cr that the event was unrelated to the device and that the patient had cardiovascular comorbidities, including chf and the cause of death was cardiac arrest.The implanting clinician also noted that the patient was under mild conscious sedation, and it should not be looked at as the main contributing factor for the occurrence.Based on this information, the patient's death was confirmed.There is no evidence that the product did not meet specifications, and the stimulator is used to treat pain.The cause of the event is unknown/no problem found.
Event or Problem Description
A complaint was received on february 8, 2021, for a patient that was sent to the hospital after complications with administered conscious sedation and subsequently passed away.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Common Device Name: SPINCAL CORD NERVE STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• MDR Report Key: 11457019
• Report Number: 3010676138-2021-00037
• Device Sequence Number: 3804640
• Product Code: GZB
• UDI-Device Identifier: 00818225020679
• UDI-Public: 010081822502067917221201
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2022
• Device Model Number: FR8A-TRL-A0
• Device Lot Number: SWO201216A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death