MAUDE Adverse Event Report: ST. JUDE MEDICAL 3 LESION NT1100 PAIN MANAGEMENT RF GENERATOR; GENERATOR, LESION, RADIOFREQUENCY

Model Number	RFG-NT-1100
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During the prf procedure, while lesioning, there were interruptions in output delivery.While attempting to lesion, there was a disruption in the delivery of current.The procedure was unable to be completed due to this issue.The system will be sent back for repair to resolved.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
One nt 1100 neurotherm rf generator was received for evaluation.The output current is outside of specification value and cannot be adjusted with potentiometer.Based on the provided information and the observed symptoms, the issue was isolated to an abnormal functioning microprocessor located on the upper assembly.Replacing the upper assembly resolved the reported problem.The generator was powered on; it initialized successfully and displayed the software application.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.Based on the information provided to abbott and the investigation performed, the root cause of the field reported issue was isolated to the potentiometer located in the upper assembly.

• Brand Name: 3 LESION NT1100 PAIN MANAGEMENT RF GENERATOR
• Common Device Name: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 12698952
• Report Number: 2184149-2021-00307
• Device Sequence Number: 11769444
• Product Code: GXD
• UDI-Device Identifier: 05415067022370
• UDI-Public: 05415067022370
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K052878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RFG-NT-1100
• Device Catalogue Number: RFG-NT-1100
• Device Lot Number: 6106214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 10/29/2021
• Patient Sequence Number: 1