MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. 4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR; GENERATOR, LESION, RADIOFREQUENCY

Model Number	RFG-NT-2000
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, with the patient on the table, the generator screen was not responding and the case was cancelled.
Additional Manufacturer Narrative
One 4 lesion nt2000¿ pain management rf generator was received for analysis.Visual inspection revealed the input, output connectors and controls appeared to be free of physical damage.All the mounting hardware was secured.Normal wear was observed on the exterior enclosure.Ac power was applied to the device and powered on, it initialized and displayed the software application.The touchscreen was unresponsive and did not respond to tactile input.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, root cause of the field reported event was successfully isolated to abnormal functionality of the microprocessor within the upper assembly.

• Brand Name: 4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR
• Common Device Name: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14117444
• Report Number: 2184149-2022-00101
• Device Sequence Number: 2356337
• Product Code: GXD
• UDI-Device Identifier: 05415067022417
• UDI-Public: 05415067022417
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K111576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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-2000
• Device Catalogue Number: RFG-NT-2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown