MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM SPINAL CORD STIMULATOR

Model Number	FR8A-RCV-A0, FR8A-SPR-B0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	09/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported a shock going down both of their legs at the start of their mri.The mri was immediately aborted.The patient is fine and feels no side effects after the mri.They have not used the device in over six months and it is unknown if an explant/revision procedure will be performed.
Additional Manufacturer Narrative
The issues after an mri questionnaire was reviewed for potential causes of the reported issue.Based on this review, not aborting the mri following the adverse event, the patient experiencing a fall, the patient having another non-stimwave device implanted, and device migration have been ruled out as potential causes.It was confirmed the mri facility followed the ifu for mri for the appropriate stimulator model.The stimulator is used to treat pain.The cause of the shock experienced during the mri is unknown.Therefore, conclusion has been selected as no problem/fault found.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in issues after an mri.Issues after an mri rates remain acceptably low; thus, capa is not required. issues after an mri rates will continue to be tracked and trended.Unable to locate the traveler for serial number (b)(4).May be in legacy netsuite database.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR
• Common Device Name: SPINAL CORD 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: 15583398
• Report Number: 3010676138-2022-00118
• Device Sequence Number: 12358757
• Product Code: GZB
• UDI-Device Identifier: 00859619004875
• UDI-Public: (01)00859619004875(17)191001(01)00818225020648(17)200201(21)207614-45
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K182720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/01/2019
• Device Model Number: FR8A-RCV-A0, FR8A-SPR-B0
• Device Catalogue Number: S8R-1A US
• Device Lot Number: SWO171024, SWO180215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown