MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. PR20XT; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	PR20XT
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing documentation could not be completed as the lot number was not provided.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.If the product or additional information is received at a later date, the investigation will be updated as applicable.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported via clinical trial ablation the patient experienced post-op pain.The pain was mild and was not a serious event.Drug therapy was given.The relationship with the study device was unlikely.The relationship with the study procedure was causal.The outcome was recovered/resolved.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/12/2022 additional information was requested and the following was obtained: adverse event term: post-op pain updated: relationship to study device value "unlikely" has been changed to "not related".
Additional Manufacturer Narrative
(b)(4).Date sent: 10/4/2023 additional information obtained: adverse event term: post-op pain severity: moderate intervention/treatment: drug therapy relationship to study device: not related upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.

• Brand Name: PR20XT
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison 53704
• Manufacturer (Section G): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison 53704
• Manufacturer Contact: kara ditty-bovard ; 3529 anderson st; madison, WI 53704 ; 6107428552
• MDR Report Key: 12729511
• Report Number: 3008769756-2021-00095
• Device Sequence Number: 14605850
• Product Code: NEY
• UDI-Device Identifier: 00853719006425
• UDI-Public: 853719006425
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PR20XT
• Device Catalogue Number: PR20XT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 06/24/2022; 10/02/2023
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 07/12/2022; 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female