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

Model Number	RFK-C101020S-P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Dizziness (2194); Discomfort (2330)
Date of Event	05/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a competitors device implanted prior to the radiofrequency ablation (rfa) procedure.After the rfa procedure was completed successfully, the patient observed the implanted device settings had changed unexpectedly without intervention.Additionally, a week after the rfa procedure, the patient experienced symptoms of headache, dizziness, and discomfort.The pain physician assumed these changes were related to the rfa procedure however, the neurosurgeon assessed that the implanted device appeared to be functioning normally.Despite this, the patient was hospitalized and underwent a revision procedure to replace the competitors device.There were no reported patient complications postoperatively.
Event or Problem Description
It was reported that the patient had a competitors device implanted prior to the radiofrequency ablation (rfa) procedure.After the rfa procedure was completed successfully, the patient observed the implanted device settings had changed unexpectedly without intervention.Additionally, a week after the rfa procedure, the patient experienced symptoms of headache, dizziness, and discomfort.The pain physician assumed these changes were related to the rfa procedure however, the neurosurgeon assessed that the implanted device appeared to be functioning normally.Despite this, the patient was hospitalized and underwent a revision procedure to replace the competitors device.There were no reported patient complications postoperatively.
Additional Manufacturer Narrative
Correction to the initial mdr: the suspect medical device reported in this mdr form for damage to a competitors device after a boston scientific rfa procedure does not meet reporting criteria.There was no reported allegation against device performance or the device itself and as such, the event should not have been reported on a 3500a mdr form.

• 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: 19822331
• Report Number: 3006630150-2024-04806
• Device Sequence Number: 8709371
• Product Code: GXI
• UDI-Device Identifier: 00813250010756
• UDI-Public: 00813250010756
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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
• Report Date (Section B): 10/25/2024

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 Model Number: RFK-C101020S-P
• Device Catalogue Number: RFK-C101020S-P
• Device Lot Number: 32748184
• 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: 06/28/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 10/25/2024
• Date Device Manufactured: 10/30/2023
• 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; Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female