MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. 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 Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

One 4 lesion nt2000" pain management rf generator was received for analysis.Visual inspection of the returned rf generator indicated all labels are intact, legible and are free of physical damage.It was also verified that all internal components were secured, and normal wear was noted on the chassis exterior.Ac power was applied to the rf generator and a successful power on self-test was executed.Inspection of the internal components revealed an electrically failed and discolored capacitor at location c49 on the radio frequency control board.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

This event is being reported due to an electrically failed and discolored capacitor of the generator.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12520470
• MDR Text Key: 272950837
• Report Number: 2184149-2021-00296
• 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: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RFG-NT-2000
• Device Catalogue Number: RFG-NT-2000
• Device Lot Number: 7496791
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2020
• Is the Device Single Use?: No
• Type of Device Usage: N
• Removal/Correction Number: 2184149-04/22/21-001-C
• Patient Sequence Number: 1