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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL 3 LESION NT1100 PAIN MANAGEMENT RF GENERATOR; GENERATOR, LESION, RADIOFREQUENCY
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ST. JUDE MEDICAL 3 LESION NT1100 PAIN MANAGEMENT RF GENERATOR; GENERATOR, LESION, RADIOFREQUENCY Back to Search Results
Model Number RFG-NT-1100
Medical Device Problem Code Insufficient Heating (1287)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/29/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances were identified that are related to the reported event.Based on the information received, the cause of the reported incident could not be determined.
 
Event or Problem Description
During the procedure, the generator would not reach the appropriate temperature and the procedure was cancelled.There were no adverse consequences to the patient.
 
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Brand Name
3 LESION NT1100 PAIN MANAGEMENT RF GENERATOR
Common Device Name
GENERATOR, LESION, RADIOFREQUENCY
Manufacturer (Section D)
ST. JUDE MEDICAL
one st. jude medical drive
st. paul MN 55117
MDR Report Key12188452
Report Number2184149-2021-00229
Device Sequence Number19180037
Product Code GXD
UDI-Device Identifier05415067022370
UDI-Public05415067022370
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K052878
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberRFG-NT-1100
Device Catalogue NumberRFG-NT-1100
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/01/2021
Initial Report FDA Received Date07/19/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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