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 Communication or Transmission Problem (2896); Impedance Problem (2950); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

Based on the information provided to abbott and the investigation performed, the reported event was not confirmed.No abnormalities that would have resulted in the reported event were identified.The generator successfully passed the power on self-test and booted to the software application menu upon applying ac power.Consistent impedance readings were observed and a successful 3 electrode lesion procedure was performed during the evaluation.Further functional testing of the generator verified consistent functionality in all modes (sensory, motor, lesion, and pulsed) and no errors were detected while monitoring the temperature and impedance readings at all ports.It was also observed no overheating error message appeared during the evaluation.The root cause cannot conclusively be determined as the reported event was not reproducible.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

Event Description

During a cervical rfa procedure, there was no impedance registered and connection errors were received while performing a three lesion burn, so the procedure was continued using a single lesion burn.During ablation, when the temperature thought to be 50 degrees an error displayed "over 98 degrees" and pain was noted at the needle site.The procedure was cancelled.

• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7430692
• MDR Text Key: 105505290
• Report Number: 2184149-2018-00046
• Device Sequence Number: 1
• Product Code: GXD
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• 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 Lot Number: 6091625
• Other Device ID Number: 05415067022417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2017
• 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
• Patient Outcome(s): Other