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

Model Number RFG-NT-2000

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425); Noise, Audible (3273)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

The results, method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During the procedure, when switching on the system, a high pitch noise and burning smell occurred.There was no visible smoke or signs of physical fire.At the time of the event the patient had the grounding pads on and the electrodes were attached to the system.The system was power cycled and when powered back on the noise was gone but a red error code appeared on the unit.The procedure was aborted due to these issues.

Manufacturer Narrative

Additional information: concomitant medical products, pma/510k, if follow-up, what type, device evaluated by mfr.One nt 2000 ix neurotherm rf generator,, was received for evaluation.The nt generator was connected to an external power source and the generator powered on successfully.When trying to connect the electrode at all channel two the generator was emitting an alarm beep and could not function.The field complaint could be confirmed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No rework or non-conformances associated with the reported event were identified.Based on the information provided to abbott and the investigation performed, the cause for the reported event was isolated to a thermal event located on a capacitor of the rf control board.

• Brand Name: 4 LESION NT2000 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: 11002526
• MDR Text Key: 221246028
• Report Number: 2184149-2020-00204
• 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,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• 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: 6784193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2184149-04/22/21-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other