MAUDE Adverse Event Report: CURONIX LLC FREEDOM SPINAL CORD STIMULATOR

Model Number FR8A-SPR-B0, FR8A-RCV-A0

Device Problem Use of Device Problem (1670)

Patient Problem Electric Shock (2554)

Event Date 08/01/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 322696470
• Report Number: 3010676138-2023-00185
• Device Sequence Number: 1
• 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
• Reporter Country Code: US
• PMA/PMN Number: K182720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• 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
• Treatment: WAA TRANSMITTER: SN (B)(6), LN: 00638-DT
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male