MAUDE Adverse Event Report: CURONIX LLC 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	Myocardial Infarction (1969)
Date of Event	03/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The other adverse events issues questionnaire was reviewed for potential causes of the reported issue.Based on this review, the incident taking place before the implant of the device, using the waa during the incident, implanting the device at an off-label location, and implanting the stimulator too close to the targeted nerve have been ruled out as potential causes.Additionally, the doctor obtained cardiac clearance before the procedure.The stimulator is used to treat pain.The cause of the cardiac arrest is unknown.Therefore, conclusion has been selected as no problem/fault found, as there is no evidence at this time that the device may have caused or contributed to the event.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in other adverse events issues.Other adverse events issues rates remain acceptably low; thus, capa is not required. other adverse events issue rates will continue to be tracked and trended.
Event or Problem Description
The patient reported cardiac arrest the day following the implant procedure.They were taken to the hospital and were in the icu as of (b)(6) 2023.The patient was not using the device when the cardiac arrest occurred and it is unknown if the device will be explanted.
Event or Problem Description
The patient reported a heart attack the day following the implant procedure.They were taken to the hospital and were in the icu.The patient was not using the device when the heart attack occurred.The patient spent approximately 6 weeks in the hospital and rehab.The patient began using their transmitter assembly on (b)(6) 2023.
Additional Manufacturer Narrative
The other adverse events issues questionnaire was reviewed for potential causes of the reported issue.Based on this review, the incident taking place before the implant of the device, using the waa during the incident, implanting the device at an off-label location, and implanting the stimulator too close to the targeted nerve have been ruled out as potential causes.Additionally, the doctor obtained cardiac clearance before the procedure.The stimulator is used to treat pain.The cause of the heart attack is unknown.The investigation findings do not lead to a clear conclusion about the cause of the reported issue.Therefore, conclusion has been selected as unable to determine root cause.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in other adverse events issues.Other adverse events issues rates remain acceptably low; thus, capa is not required. other adverse events issue rates will continue to be tracked and trended.Updated per fda capa-2023-0013 correction 2.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): CURONIX LLC; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer (Section G): CURONIX LLC; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer Contact: alicia pagliaro ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 16745269
• Report Number: 3010676138-2023-00047
• Device Sequence Number: 17824308
• Product Code: GZB
• UDI-Device Identifier: 00818225020693
• UDI-Public: (01)00818225020693(17)230701(01)00818225020648(17)240301(21)2B14768-19
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2024

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: 07/01/2023
• Device Model Number: FR8A-RCV-A0, FR8A-SPR-B0
• Device Lot Number: SWO210712, SWO220322
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2021
• 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: Hospitalization
• Patient Sex: Unknown