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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEUROTHERM, INC 3 LESION NT1100¿ PAIN MANAGEMENT RF GENERATOR; GENERATOR, LESION, RADIOFREQUENCY
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NEUROTHERM, INC 3 LESION NT1100¿ PAIN MANAGEMENT RF GENERATOR; GENERATOR, LESION, RADIOFREQUENCY Back to Search Results
Model Number RFG-NT-1100
Device Problems Impedance Problem (2950); Temperature Problem (3022)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2018
Event Type  Injury  
Event Description
During a procedure the generator gave error message "impedance failure" at the self test.There were also issues with impedance and probe temperature.There were no adverse consequences to the patient but the procedure was cancelled.
 
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The customer did not return the product for evaluation and repair as they are purchasing a new replacement device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
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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 Key8148679
MDR Text Key129839752
Report Number3002953813-2018-00093
Device Sequence Number1
Product Code GXD
Combination Product (y/n)N
PMA/PMN Number
K052878
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberRFG-NT-1100
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/13/2018
Patient Sequence Number1
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