MAUDE Adverse Event Report: NEUROTHERM, INC NT500 PAIN MANAGEMENT RF GENERATOR; GENERATOR, LESION, RADIOFREQUENCY

Model Number RFG-NT-500

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2017

Event Type  Injury  

Event Description

During the procedure, the temperature did not increase and no impedance was displayed.The probe and grounding pad were exchanged which did not resolve the issue.The patient was under local anesthesia and the probe was inserted.The procedure was aborted with no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).The reported temperature issue and impedance issue was unable to be confirmed.Field service testing of the device confirmed that the device functioned properly.The cause for the reported event was not able to be confirmed as the temperature and impedance issues reported were not reproduced.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• Brand Name: NT500 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: 7125111
• MDR Text Key: 95180563
• Report Number: 3002953813-2017-00055
• Device Sequence Number: 1
• Product Code: GXD
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RFG-NT-500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2015
• 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