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

Model Number RFG-NT-1100

Device Problem Impedance Problem (2950)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

During the procedure, the generator did not recognize the auto testing of the impedances and the procedure was cancelled.Four different probes were tested and the generator was restarted, but the issue remained.There were no adverse consequences to the patient.

Manufacturer Narrative

One nt 1100 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.All modes (sensory, motor, lesion, and pulsed) were examined in this investigation.Testing of all ports was conducted while monitoring the port temps 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 cannot be conclusively determined as no abnormalities were identified.The returned product operated as anticipated during the evaluation period.

• Brand Name: 3 LESION NT1100 PAIN MANAGEMENT RF GENERATOR
• Type of Device: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11281251
• MDR Text Key: 231407643
• Report Number: 2184149-2021-00034
• Device Sequence Number: 1
• Product Code: GXD
• UDI-Device Identifier: 05415067022370
• UDI-Public: 05415067022370
• Combination Product (y/n): N
• PMA/PMN Number: K052878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RFG-NT-1100
• Device Catalogue Number: RFG-NT-1100
• Device Lot Number: 6814612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1