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

Model Number RFK-C101022S

Device Problem Defective Device (2588)

Patient Problem No Code Available (3191)

Event Date 09/24/2020

Event Type  Injury  

Event Description

It was reported that during a cervical rfa, radiofrequency ablation, procedure the probe would not descend down the cannula, thereby causing the patient to be stuck more than once.The date of the event is unknown.No additional information was provided.

• Type of Device: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 10708104
• MDR Text Key: 212248070
• Report Number: 3006630150-2020-05023
• Device Sequence Number: 1
• Product Code: GXI
• UDI-Device Identifier: 00813250012545
• UDI-Public: 00813250012545
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/09/2022
• Device Model Number: RFK-C101022S
• Device Catalogue Number: RFK-C101022S
• Device Lot Number: P754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention