MAUDE Adverse Event Report: CURONIX LLC FREEDOM SPINAL CORD STIMULATOR

Model Number	FR8A-SPR-B0, FR8A-RCV-A0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	08/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported shock during an mri scan.The mri was aborted.The patient's device was reprogrammed and is reducing the patient's pain by 50%.Additionally, the patient is not experiencing any adverse events following the mri.
Additional Manufacturer Narrative
The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, the waa providing therapy when unintended stimulation/new pain occurred and changes to the waa parameters, intentionally or unintentionally, before the event have been ruled out as potential causes.However, the questionnaire shows the patient has a non-curonix device (heart monitor) implanted.The stimulator is used to treat pain.The cause of the reported issue is due to interference of a non-curonix device as the patient has an implanted heart monitor (user error).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in unintended stimulation/new pain issues.Unintended stimulation/new pain issue rates remain acceptably low; thus, capa is not required. unintended stimulation/new pain issue rates will continue to be tracked and trended.

• 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: 17687792
• Report Number: 3010676138-2023-00185
• Device Sequence Number: 14960503
• Product Code: GZB
• UDI-Device Identifier: 00818225020648
• UDI-Public: (01)00818225020648(17)240301(01)00818225020693(17)231001(21)2B13955-47
• 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: 2022
• 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): 09/05/2023

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: 03/01/2024
• Device Model Number: FR8A-SPR-B0, FR8A-RCV-A0
• Device Lot Number: SWO220322, SWO211025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WAA TRANSMITTER: SN (B)(6), LN: 00638-DT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male