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

Model Number CR-10-P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 09/12/2018

Event Type  Injury  

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 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 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.

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.

• Type of Device: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): COSMAN MEDICAL, LLC; 22 terry avenue; burlington MA 01803
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 7928058
• MDR Text Key: 122446045
• Report Number: 3006630150-2018-61153
• Device Sequence Number: 1
• Product Code: GXI
• UDI-Device Identifier: 00813250010916
• UDI-Public: 00813250010916
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K082012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2018
• 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