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 12/06/2017

Event Type  Injury  

Manufacturer Narrative

Based on the information provided to abbott and the investigation performed, the results of the evaluation confirmed the field reported event as the generator failed the testing impedance during the evaluation.The root cause has been isolated to an abnormal test resistor located at the microprocessor board.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

Event Description

During preparation for the procedure an impedance error of "1999" occurred on the generator and the impedance reading was incorrect.The patient had been prepped and was on the table when the case was cancelled.There were no adverse patient consequences.

• 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: 7160051
• MDR Text Key: 96337840
• Report Number: 3002953813-2017-00058
• Device Sequence Number: 1
• Product Code: GXD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• 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: 12/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2008
• 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