MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP MULTIGEN2 RF GENERATOR; GENERATOR, LESION, RADIOFREQUENCY

Model Number	8400-000-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Inadequate Pain Relief (2388)
Date of Event	05/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient noted severe pain and a "sunburn feeling" on the left lumbar spine following an l3-s1 procedure.Lidocaine and marcaine were in use for local anesthetic and propofol was used for general anesthesia.The console was set to 80°c, and no malfunction was alleged with the equipment.The ablation procedure itself was completed but unsuccessful for the treatment of pain.The patient returned for facet joint injections consisting of lidocaine, marcaine, and dexamethasone to treat dysesthesia due to wallerian degeneration that was alleged to have occurred during the original ablation procedure.
Event or Problem Description
It was reported that the patient noted severe pain and a "sunburn feeling" on the left lumbar spine following an l3-s1 procedure.Lidocaine and marcaine were in use for local anesthetic and propofol was used for general anesthesia.The console was set to 80°c, and no malfunction was alleged with the equipment.The ablation procedure itself was completed but unsuccessful for the treatment of pain.The patient returned for facet joint injections consisting of lidocaine, marcaine, and dexamethasone to treat dysesthesia due to wallerian degeneration that was alleged to have occurred during the original ablation procedure.
Additional Manufacturer Narrative
Corrected data: this report was filed in error.Upon further investigation and expert medical opinion, the reported event is a potential known side effect of rf procedures.The subsequent injection for pain was not required to treat or prevent permanent impairment.Additional information: d9.

• Brand Name: MULTIGEN2 RF GENERATOR
• Common Device Name: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 12124499
• Report Number: 3015967359-2021-01319
• Device Sequence Number: 4723650
• Product Code: GXD
• UDI-Device Identifier: 07613327173642
• UDI-Public: 07613327173642
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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 Model Number: 8400-000-000
• Device Catalogue Number: 8400000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 09/15/2021
• 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: Required Intervention