MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-ST. PAUL) 3 LESION NT1100¿ PAIN MANAGEMENT RF GENERATOR; GENERATOR, LESION, RADIOFREQUENCY

Model Number	RFG-NT-1100
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported issue was confirmed.Based on the information provided to abbott and the investigation performed, isolated to multiple circuit boards becoming dislodged from the midplane, or mother board.The event which resulted in the circuit boards becoming dislodged was not communicated and remains undetermined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.No capa is required; the root cause of the reported issue could not be confirmed to be a manufacturing, design, or quality system related occurrence.The reported issue will continue to be monitored for trends and reviewed in qdr (quality data review).
Event or Problem Description
During the procedure, it was reported that the voltage was not reaching targeted level.As a result, the procedure could not be completed.There was no adverse consequence to the patient.

• Brand Name: 3 LESION NT1100¿ PAIN MANAGEMENT RF GENERATOR
• Common Device Name: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (AF-ST. PAUL); one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (AF-ST. PAUL); one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 16530422
• Report Number: 2184149-2023-00061
• Device Sequence Number: 11424223
• Product Code: GXD
• UDI-Device Identifier: 05415067022370
• UDI-Public: 05415067022370
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K052878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2023

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 Number: RFG-NT-1100
• Device Catalogue Number: RFG-NT-1100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2006
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 91 KG