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

Model Number RFG-NT-1100

Device Problem Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2018

Event Type  Injury  

Event Description

During the procedure, there was no impedance readings on the generator and the procedure was cancelled.Motor and sensory tests were able to be completed however no impedance was available.The procedure was rescheduled and there were no adverse consequences to the patient due to the cancellation.

Manufacturer Narrative

Additional information: 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: elizabeth boltz ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7732540
• MDR Text Key: 115467935
• Report Number: 3002953813-2018-00049
• Device Sequence Number: 1
• Product Code: GXD
• UDI-Device Identifier: 05415067022370
• UDI-Public: 05415067022370
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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