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

Model Number RFG-NT-2000

Device Problems Insufficient Heating (1287); Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.Further information regarding the event were requested but not received.

Event Description

During a procedure, the probes were not exceeding the ambient temperature and there was sporadic impedance.Troubleshooting included checking the grounding pad, restarted the lesion, restarting the device, changing adaptors, changing the electrodes and ablating with only one probe at a time.The procedure was cancelled.

Event Description

There were no patient consequences.

Manufacturer Narrative

One 4 lesion nt2000¿ pain management rf generator was received for investigation.Ac power was applied to the generator and a successful power on self-test was observed.All four ports were tested for functionality upon which the user defined target temperatures were monitored and achieved successfully on all ports and all port indicator lights remained green throughout testing.No faults, warnings, irregular heating periods or abnormal display were encountered during the evaluation.Review of the engineering log files proved inconclusive as no hardware failures or abnormal values were observed for the reported event date.Based on the information provided to abbott and the investigation performed, the root cause of the field reported event citing abnormal temperature & impedance values could not be conclusively determined as the returned generator functioned as anticipated throughout investigation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

Manufacturer Narrative

Additional information: g4, g7, h2, h3, h6, h10.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• Brand Name: 4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR
• Type of Device: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 9330033
• MDR Text Key: 166626975
• Report Number: 2184149-2019-00227
• Device Sequence Number: 1
• Product Code: GXD
• UDI-Device Identifier: 05415067022417
• UDI-Public: 05415067022417
• Combination Product (y/n): N
• PMA/PMN Number: K111576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RFG-NT-2000
• Device Catalogue Number: RFG-NT-2000
• Device Lot Number: 6025253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/15/2019
• Supplement Dates Manufacturer Received: 11/26/2019; 01/06/2020; 03/03/2020
• Supplement Dates FDA Received: 12/19/2019; 01/29/2020; 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other