MAUDE Adverse Event Report: NEUROTHERM, INC 3 LESION NT1100¿ PAIN MANAGEMENT RF GENERATOR; GENERATOR, LESION, RADIOFREQUENCY

Model Number RFG-NT-1100

Device Problems Impedance Problem (2950); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2018

Event Type  Injury  

Event Description

During an ablation procedure, the generator was not reading impedance or temperature accurately and the procedure was cancelled.There were no patient consequences.

Manufacturer Narrative

The results of the investigation are inconclusive since the device(s) were not returned for analysis.It was not able to be confirmed which generator of two at the account were used during the reported procedure.Based on the information received, the cause of the reported impedance and temperature issue could not be conclusively determined.The device history records for each possible serial number (b)(4) were reviewed to ensure that each manufacturing and inspection operation was performed.

• Brand Name: 3 LESION NT1100¿ PAIN MANAGEMENT RF GENERATOR
• Type of Device: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): NEUROTHERM, INC; 600 research drive ste 1; wilmington MA 01887
• MDR Report Key: 7573397
• MDR Text Key: 110220412
• Report Number: 3002953813-2018-00032
• Device Sequence Number: 1
• Product Code: GXD
• Combination Product (y/n): N
• PMA/PMN Number: K052878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RFG-NT-1100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other