MAUDE Adverse Event Report: ST. JUDE MEDICAL NEUROTHERM SL PREMIUM CURVED RF NEEDLE, 20G, 15CM; PROBE, RADIOFREQUENCY LESION

Model Number	SL-C1510-20
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During the procedure, two rf cannulas were used for a bilateral injection to the sij.While removing the rf cannula, part of the isolation of one of the cannulas was ripped and remained in the body of the patient.The piece was unable to be felt through the skin and it was thought to have been within the deeper tissue.The patient was discharged in stable condition with no adverse patient consequences.
Additional Manufacturer Narrative
One 15 cm, 20 g neurotherm rf needle was received for evaluation.One image was also submitted showing the needle with torn white material.Based on the information presented above, the curved active tip had part of its isolation ripped off.Unit analysis was completed and confirmed that the white insulation material was torn and detached from the cannula needle.During abbott process there are no cutting methods that could potentially rip the insulation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn insulation remains unknown.

• Brand Name: NEUROTHERM SL PREMIUM CURVED RF NEEDLE, 20G, 15CM
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 10941306
• Report Number: 2182269-2020-00106
• Device Sequence Number: 14535434
• Product Code: GXI
• UDI-Device Identifier: 05415067028259
• UDI-Public: 05415067028259
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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: 06/30/2022
• Device Model Number: SL-C1510-20
• Device Catalogue Number: SL-C1510-20
• Device Lot Number: 7108450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 04/07/2021
• 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