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

Model Number	TCN-10-3M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that blood seeped into where the probe attaches to the stainless head of the electrode.The blood could not be removed and kept seeping out despite attempts of sterilization.

• Brand Name: NA
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 14289701
• Report Number: 3006630150-2022-02049
• Device Sequence Number: 13842784
• Product Code: GXI
• UDI-Device Identifier: 00813250017502
• UDI-Public: 00813250017502
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2022

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: TCN-10-3M
• Device Catalogue Number: TCN-10-3M
• Device Lot Number: 23376868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2019
• 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: Required Intervention
• Patient Sex: Unknown