MAUDE Adverse Event Report: ABBOTT MEDICAL (SH-PLYMOUTH) NEUROTHERM¿ SL PREMIUM CURVED RF NEEDLE, 20G, 15CM; PROBE, RADIOFREQUENCY LESION

Model Number	SL-C1510-20
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced with a red ring around the needle insertion site following a rf procedure.The healthcare provided determined it was an unknown allergic reaction to silicone.The reported red ring has resolved on its own.
Additional Manufacturer Narrative
The reported event of a red ring around the needle insertion site could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: NEUROTHERM¿ SL PREMIUM CURVED RF NEEDLE, 20G, 15CM
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): ABBOTT MEDICAL (SH-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL (SH-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18828044
• Report Number: 3005334138-2024-00067
• Device Sequence Number: 15383725
• Product Code: GXI
• UDI-Device Identifier: 05415067028259
• UDI-Public: 05415067028259
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K000073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024

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: 03/31/2024
• Device Model Number: SL-C1510-20
• Device Lot Number: 7935959
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown