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

Model Number	CR-10-P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	09/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model: cr-10-p; serial/lot: (b)(4); description: injection electrode: 10cm, 5mm tip.The devices were not returned to bsn as they were discarded by the medical facility.
Event or Problem Description
A report was received that the patient developed two welts or bumps on the skin where the needles had been placed.The physician believed it was a burn but did not do diagnostic checks to confirm.There was no intervention to treat the burn.
Event or Problem Description
A report was received that the patient underwent a radiofrequency degeneration procedure.The patient developed two welts or bumps on the skin where the needles had been placed.The physician believed it was a burn but did not do diagnostic checks to confirm.There was no intervention to treat the burn.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model: cr-10-p, serial/lot: (b)(4), description: injection electrode: 10cm, 5mm tip.The devices were not returned to bsn as they were discarded by the medical facility.A review of the manufacturing documentation for the devices revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.

• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 7928058
• Report Number: 3006630150-2018-61153
• Device Sequence Number: 13815332
• Product Code: GXI
• UDI-Device Identifier: 00813250010916
• UDI-Public: 00813250010916
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K082012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2022
• Device Model Number: CR-10-P
• Device Catalogue Number: CR-10-P
• Device Lot Number: P906
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1