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	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances were identified that are related to the reported event.Based on the information received, the cause of the reported incident could not be determined.
Event or Problem Description
During the procedure, the generator would not reach a temperature above 34-38 degrees celsius and the procedure had to be cancelled.The grounding pad and impedance levels were checked and single electrode mode was attempted, but the issue remained.There were no adverse consequences to the patient.

• 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: 12303081
• Report Number: 2184149-2021-00236
• Device Sequence Number: 3612684
• Product Code: GXD
• UDI-Device Identifier: 05415067022370
• UDI-Public: 05415067022370
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2021

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: 7079965
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1