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

Model Number RFG-NT-2000

Device Problem Thermal Decomposition of Device (1071)

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

Event Type  malfunction  

Manufacturer Narrative

One 4 lesion nt2000¿ pain management rf generator was received to service.Inspection of the rf control board showed burnt components near tr28.Additionally, tp14 was damaged, resulting in the inability of capacitance readings to be taken from that location.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 issue was isolated to abnormal functionality of the radio frequency control board.

Event Description

During service of the system, the rf control board had burnt components near tr28.The rf board was replaced to resolve the issue.There was no patient involved.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12759724
• MDR Text Key: 280439643
• Report Number: 2184149-2021-00350
• Device Sequence Number: 1
• Product Code: GXD
• UDI-Device Identifier: 05415067022417
• UDI-Public: 05415067022417
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/05/2021

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
• Device Operator: Other
• Device Model Number: RFG-NT-2000
• Device Catalogue Number: RFG-NT-2000
• Device Lot Number: 6558242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1