MAUDE Adverse Event Report: CURONIX LLC FREEDOM SPINAL CORD STIMULATOR; TRANSMITTER ASSEMBLY

Model Number PDBT-915-2K

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burning Sensation (2146)

Event Date 05/02/2023

Event Type  Injury  

Manufacturer Narrative

The clinical representative has not been able to retrieve the transmitter associated with rma 2023-08567 to be sent to curonix headquarters for the engineering investigation.The waa heat related failure was reviewed for potential causes of the reported issue.Based on this review, placing the device directly on the skin has been ruled out as a potential cause.Other potential causes of overheating are charger/cable short, misuse of the cable (forced entry of the charger cord into the waa), pcb failure, battery failure, thermal cutoff not working and excessive battery current.The stimulator is used to treat pain. the cause of the reported issue 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 no problem found.No problem found rates remain acceptably low; thus, capa is not required.No problem found rates will continue to be tracked and trended.

Event Description

The patient reported their wearable antenna assembly was overheating and causing a burning sensation to the skin.The overheating did not cause tissue damage or require medical intervention.The patient was provided a replacement waa.

Event Description

The patient reported their wearable antenna assembly was overheating and causing a burning sensation to the skin.The overheating did not cause tissue damage or require medical intervention.The patient was provided a replacement waa.

Manufacturer Narrative

The investigation found the power amplifier was damaged (failure mode is low impedance), triggering the "low power detect" alarm and causing the battery overcurrent protection to trip within a few seconds.Therefore, the device cannot deliver therapy.Due to the damaged power amplifier, the device does not operate.Therefore, unable to obtain thermal images.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in blown power amplifier.Blown power amplifier rates remain acceptably low; thus, capa is not required.Blown power amplifier rates will continue to be tracked and trended.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR
• Type of Device: TRANSMITTER ASSEMBLY
• 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: 17021113
• MDR Text Key: 316282802
• Report Number: 3010676138-2023-00069
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020150
• UDI-Public: (01)00818225020150
• 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,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PDBT-915-2K
• Device Lot Number: 00576-DT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2022
• 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
• Patient Age: 70 YR
• Patient Sex: Female