MAUDE Adverse Event Report: MEDTRONIC, INC. PENDITURE; LEFT ATRIAL APPENDAGE CLIP, IMPLANTABLE

Model Number	PROM35
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon attempted to deploy and it did not work.
Event or Problem Description
The surgeon attempted to deploy and it did not work.
Additional Manufacturer Narrative
The following elements have blank data: [device identifier (di):] for type of device: left atrial appendage clip, implantable.

• Brand Name: PENDITURE
• Common Device Name: LEFT ATRIAL APPENDAGE CLIP, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 7555 innovation way; mason OH 45040
• MDR Report Key: 24002864
• Report Number: 24002864
• Device Sequence Number: 10523093
• Product Code: PZX
• UDI-Device Identifier: 10840143913563
• UDI-Public: (01)10840143913563
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025
• Report Date (Section F): 12/23/2025

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
• Device Model Number: PROM35
• Device Catalogue Number: LAAC35
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/08/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 01/27/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 12/23/2025