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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. 4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR; GENERATOR, LESION, RADIOFREQUENCY
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ST. JUDE MEDICAL, INC. 4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR; GENERATOR, LESION, RADIOFREQUENCY Back to Search Results
Model Number RFG-NT-2000
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
During service, thermal damage was noted on a rf control board capacitor.The investigation revealed that the capacitor on the rf control board failed within two years of service.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.
 
Event Description
During service, thermal damage was noted on a rf control board capacitor.
 
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Brand Name
4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR
Type of Device
GENERATOR, LESION, RADIOFREQUENCY
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
one st. jude medical drive
st. paul MN 55117
MDR Report Key12749006
MDR Text Key280006568
Report Number2184149-2021-00354
Device Sequence Number1
Product Code GXD
UDI-Device Identifier05415067022417
UDI-Public05415067022417
Combination Product (y/n)N
PMA/PMN Number
K111576
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Remedial Action Recall
Type of Report Initial
Report Date 11/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberRFG-NT-2000
Device Catalogue NumberRFG-NT-2000
Device Lot Number7566694
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2021
Was the Report Sent to FDA? No
Date Manufacturer Received11/03/2021
Date Device Manufactured07/06/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number2184149-04/22/21-001-C
Patient Sequence Number1
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