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	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the generator was not able to recognize the adapter cable and the grounding pad and the procedure was cancelled.There were no adverse consequence to the patient.
Additional Manufacturer Narrative
One nt 1000 neurotherm rf generator was received for investigation.No visual anomalies were detected in this visual inspection.Ac power was applied to the rf generator and the system was powered on successfully.The reported communication issue was not reproduced.The returned product functioned properly during the evaluation.All modes (sensory, motor, lesion, and pulsed) were examined in this investigation.Testing of all ports was conducted while monitoring the port temperatures and impedance.Audible tones emitted were consistent with the modes of operation selected.No hardware anomalies were detected in this investigation.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 provided to abbott and the investigation performed, the root cause of the field reported event cannot be conclusively determined as no abnormalities were identified.The returned product operated as designed during the evaluation period.

• 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: 11980388
• Report Number: 2184149-2021-00192
• Device Sequence Number: 3831717
• Product Code: GXD
• UDI-Device Identifier: 05415067022370
• UDI-Public: 05415067022370
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 07/07/2021

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: 11539-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1