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

Model Number RFG-NT-1100

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The pulse mode did not work on the generator.The procedure was canceled and rescheduled for a different day.There were no adverse consequences to the patient.

Manufacturer Narrative

Based on the information provided to abbott and the investigation performed, the reported event was unable to be confirmed.The returned product functioned properly during the evaluation.No hardware abnormalities that would have resulted in the reported event were identified.

• 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
• Manufacturer (Section G): NEUROTHERM, INC; 600 research drive ste 1; wilmington MA 01887
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6801080
• MDR Text Key: 82929762
• Report Number: 3002953813-2017-00025
• Device Sequence Number: 1
• Product Code: GXD
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K052878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RFG-NT-1100
• Other Device ID Number: 05415067022370
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/12/2011
• 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