MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Aveir¿ Leadless Pacemaker, Right Ventricle

Model Number	LSP112V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient presented remotely via merlin.Net with an alert of polarity switch due to high pacing impedance on the atrial lead.The atrial lead also exhibited oversensing noise, high capture threshold, undersensing, and poor sensing.Atrial sensitivity was reprogrammed to 0.5mv at the time of check.Additionally, there was also mention of pacemaker lead infection.No further changes or interventions were reported.The patient condition was not reported.
Event or Problem Description
New information received indicates that the transvenous pacemaker and leads were explanted on (b)(6) 2026.The aveir leadless pacemaker was attempted to be implanted on (b)(6) 2026, but the physician was unsuccessful.No further information is known.
Additional Manufacturer Narrative
Review of the sterilization records confirmed normal sterilization cycles for the products.The device met specifications prior to leaving abbott manufacturing facilities.The cause of infection could not be determined.

• Brand Name: Aveir¿ Leadless Pacemaker, Right Ventricle
• Common Device Name: Leadless Pacemaker
• Manufacturer (Section D): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 50595891
• Report Number: 2017865-2026-18670
• Device Sequence Number: 9496987
• Product Code: PNJ
• UDI-Device Identifier: 05415067034472
• UDI-Public: (01)05415067034472(10)S000112163(17)280312
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: P150035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

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: LSP112V
• Device Lot Number: S000112163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown