MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; PROBE, RADIOFREQUENCY LESION

Model Number	TC-11-2-250-D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following a radiofrequency ablation (rfa) procedure, the patient experienced hypoactive delirium.The patient had a delayed awakening after the rfa procedure.The patient stayed in the intensive care unit and the event resolved the following day.The event was assessed as possibly procedure related.
Event or Problem Description
It was reported that following a radiofrequency ablation (rfa) procedure, the patient experienced hypoactive delirium.The patient had a delayed awakening after the rfa procedure.The patient stayed in the intensive care unit and the event resolved the following day.The event was assessed as possibly procedure related.Additional information was received that the event was assessed as not device related.
Event or Problem Description
It was reported that following a radiofrequency ablation (rfa) procedure, the patient experienced hypoactive delirium.The patient had a delayed awakening after the rfa procedure.The patient stayed in the intensive care unit and the event resolved the following day.The event was assessed as possibly procedure related.Additional information was received that the event was assessed as not device related.
Event or Problem Description
It was reported that following a radiofrequency ablation (rfa) procedure, the patient experienced hypoactive delirium.The patient had a delayed awakening after the rfa procedure.The patient stayed in the intensive care unit and the event resolved the following day.The event was assessed as possibly procedure related.Additional information was received that the event was assessed as not device related.The event was assessed by the physician as not related to the device but possibly related to the rfa procedure.During the rfa procedure, right thalamotomy was performed with no complications.Following the procedure, the clinical study patient experienced hypoactive delirium and delayed awakening.The patient was admitted to the intensive care unit and the event resolved the following day.The patient was stable at discharge.After the treating physicians consultation with neurology, the hypoactive delirium was diagnosed in the context of advanced parkinsons disease.The rf disposable electrode is not being returned to bsc for laboratory analysis as there was no device malfunction reported.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: brand name: cosman rfg-4, upn: rfg-4-220v, model: rfg-4-220v, serial: (b)(6), batch: g4100535, upn: (b)(4).

• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22130656
• Report Number: 3006630150-2025-03888
• Device Sequence Number: 20934730
• Product Code: GXI
• UDI-Device Identifier: 00813250014495
• UDI-Public: (01)00813250014495(17)240517(10)25519991
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2024
• Device Model Number: TC-11-2-250-D
• Device Catalogue Number: TC-11-2-250-D
• Device Lot Number: 25519991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 06/03/2025; 07/31/2025; 08/28/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 06/19/2025; 08/25/2025; 09/10/2025
• Date Device Manufactured: 05/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown