MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. NEUWAVE PR XT PROBE 20CM 15GA; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	PR20XT
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Not enough data provided to perform a call home investigation.No device will be returned to neuwave for further investigation.The root cause is unknown.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.No further investigation will be conducted on this complaint due to no device return.Complaint information will be included in complaint trending that is reviewed by the applicable pqss drb on a regular basis to determine if further action is necessary.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 that during a clinical trial (b)(6) ablation the patient experienced pain.The patient required prolonged in-patient hospitalization with drug therapy.The device relationship with the pain is unlikely and the procedure relationship with the pain is probable.The patient's outcome is recovered/resolved.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/3/2022.Additional information was requested and the following was obtained: adverse event term: abdominal pain relationship to study device value "unlikely" has been changed to "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: NEUWAVE PR XT PROBE 20CM 15GA
• 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: 12459555
• Report Number: 3008769756-2021-00086
• Device Sequence Number: 5156266
• Product Code: NEY
• UDI-Device Identifier: 00853719006425
• UDI-Public: 00853719006425
• 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: Study,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2021

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?: 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: 08/16/2021
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 08/03/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female