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

Model Number	CR-10-P
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Superficial (First Degree) Burn (2685)
Date of Event	09/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing documentation for the cannula revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.A review of the sterilization documentation for the device(s) was found to be satisfactory.
Event or Problem Description
A report was received that a week following the rf ablation procedure the patient developed 4 wheals or bumps at the location of the needle insertion.
Additional Manufacturer Narrative
Additional information was received that the patient did not have an allergic reaction.The physician thought it may have been a burn, however, no test was done to confirm it and no intervention was required.
Event or Problem Description
A report was received that a week following the rf ablation procedure the patient developed 4 wheals or bumps at the location of the needle insertion.

• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 7939801
• Report Number: 3006630150-2018-61216
• Device Sequence Number: 1998638
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2018

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?: No
• 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: 10/06/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other