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

Model Number	CSK-TC10
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that the patient underwent a radiofrequency ablation (rfa) procedure during which an electrode became detached from the connector while inside the patient.The outcome of the procedure was unable to be obtained.
Event or Problem Description
It was reported that the patient underwent a radiofrequency ablation (rfa) procedure during which an electrode became detached from the connector while inside the patient.The outcome of the procedure was unable to be obtained.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d2b: gxd, gxi.
Additional Manufacturer Narrative
Correction the initial mdr: the suspect medical device reported in this mdr form for a broken electrode does not meet reporting criteria.The broken electrode was discovered after the procedure was completed; as such, there was no reported harm to the patient.As there was no serious injury, the event should not have been reported on a 3500a mdr form.B3: approximated based on the date the manufacturer became aware of the event.D2b: gxd, gxi.
Event or Problem Description
It was reported that the patient underwent a radiofrequency ablation (rfa) procedure during which an electrode became detached from the connector while inside the patient.The outcome of the procedure was unable to be obtained.After further review, the broken electrode was discovered post-procedure and did not occur inside the patient.As such, there was no reported patient harm.

• Brand Name: NA
• Common Device Name: GENERATOR, LESION, RADIOFREQUENCY
• 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: 19967031
• Report Number: 3006630150-2024-05266
• Device Sequence Number: 8897604
• Product Code: GXD
• UDI-Device Identifier: 00813250010107
• UDI-Public: 00813250010107
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K050084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/31/2024

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: CSK-TC10
• Device Catalogue Number: CSK-TC10
• Device Lot Number: 30952831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 10/17/2024; 12/06/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 11/08/2024; 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown